NOVA BIOMEDICAL StatStrip Xpress Instructions For Use Manual
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NOVA BIOMEDICAL StatStrip Xpress Instructions For Use Manual

NOVA BIOMEDICAL StatStrip Xpress Instructions For Use Manual

Glucose hospital meter
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Glucose Hospital Meter
Instructions for Use Manual

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  • Page 1 Nova StatStrip Xpress ® Glucose Hospital Meter Instructions for Use Manual...

  • Page 3: Table Of Contents

    Table of Contents Symbols..................1 About.This.Manual...............2 Safety..................3 Intended.Use................6 Introduction..................9 CLIA.Complexity..............9 Clinical.Utility................14 The.Sample................14 Interfering.Substances............15 Operation.Overview...............16 Meter.Sleep/Wakeup..............17 Setup..................19 Installing.the.Battery.(Replacing)...........19 Set.the.Time................21 Set.Date.Format..............24 Beeper.On.or.Off..............28 Testing:.QC/Linearity/Proficiency/Blood.Samples.....30 When.to.Perform.a.QC.Test...........30 StatStrip.Glucose.Control.Solution........31...
  • Page 4 Table of Contents Testing.a.Quality.Control.Solution..........33 Testing.a.Blood.Sample............36 Testing.a.Linearity/Proficiency.Solution.........41 Reviewing.Test.Results............44 Deleting.Stored.Test.Results..........45 Troubleshooting.................47 Battery.Check................47 Error.Codes................51 Appendix...................55 A.1.Specifications..............56 A.2.Reference.Values............57 A.3.Glucose.Methodology............58 A.4.Quality.Control.Solution...........59 A.5.Chemistry.Measurement..........59 A.6.Ordering.Information............60 A.7.Cleaning.and.Care............61 A.8.Results.of.CLIA.Waiver.Study..........63 Warranty..................75...

  • Page 5: Symbols

    Symbols The following are symbols that are used in this manual, on insert sheets, and on the meter. In vitro diagnostic medical Electronic Waste device Authorized Representative Catalog number in the European Community Product fulfills the requirements Temperature limitation of Directive 98/79 EC (IVDD) Caution, consult accompanying documents Upper Limit of Temperature...

  • Page 6: About.this.manual

    About This Manual This manual is for the Nova Biomedical StatStrip Xpress™ Glucose Hospital Meter. Unit of Measure Information The unit of measure of the StatStrip Xpress Glucose Hospital Meter is factory set to the standards in the country of use. The Meter either reports glucose results in mg/dL, 43404, or mmol/L, 44321, and can not be changed.

  • Page 7: Safety

    Safety Personnel operating this meter must be proficient in the operating and maintenance procedures of the meter. The following safety procedures must be followed. 1. Read the safety and operating instructions before operating the meter. 2. Retain the safety and operating instructions for future reference.
  • Page 8 Safety Electrical Safety 1. Battery powered: 3-volt coin battery Chemical and Biological Safety 1. Observe all precautionary information printed on the original solution containers. 2. Operate the meter in the appropriate environment. 3. Dispose of all waste solutions according to standard hospital procedures.
  • Page 9 Safety applicable collection point for the recycling of electri- cal and electronic equipment. Disposal of Used Meters for customers in Europe: • The meter may become infectious during the course of use. Discard in accordance with local regulations for biohazardous waste. Environmental •...

  • Page 10: Intended.use

    Weight: 75 g (2.65 oz) Intended Use The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care profes- sionals and for point-of-care usage in the quantitative deter- mination of Glucose (Glu) in capillary, venous, and arterial whole blood and neonatal capillary whole blood.
  • Page 11 Glucose Test Strip LCD Display mg/dL mmol/L Left Arrow Button Right Arrow Button Mode Button Result in mg/dL Result in mmol/L Nova StatStrip Xpress Glucose Hospital Meter...
  • Page 12 Glucose Beeper ON Indicator Glucose Test Blood or Control Result Drop Indicator Test Result mg/dL or mmol/L Low Battery Indicator Memory AM or PM Indicator Date/Day Hour/Minute Nova StatStrip Xpress Glucose Hospital Meter Screen...

  • Page 13: Introduction

    Introduction CLIA Complexity This test is WAIVED for capillary, venous, and arterial whole blood and neonatal capillary whole blood under the Clini- cal Laboratory Improvements Amendments of 1988 (CLIA). Laboratories with a Certificate of CLIA waiver can perform this test in a waived setting and must follow the manufac- turer’s instructions for performing the test.
  • Page 14 Introduction WARNING: Healthcare professionals and others using this system on multiple patients should be aware that all products or objects that come into contact with human blood should be handled as if ca- pable of transmitting viral diseases, even after cleaning. Precaution: •...
  • Page 15 Introduction • Prior to use, read the StatStrip Glucose Meter In- structions for Use Manual. • DO NOT reuse test strips. Strips are designed to be disposed after a single use. • Discard used test strips according to local regulations. •...
  • Page 16 Introduction Additional Information for Healthcare Professionals • The Nova StatStrip Glucose Test Strips are calibrated against plasma. • The Nova StatStrip Glucose Test Strips are used for whole blood testing only.
  • Page 17 Introduction The Nova StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions.

  • Page 18: Clinical.utility

    Introduction Clinical Utility The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by health care professionals as an aid to monitor the effectiveness of diabetes control.

  • Page 19: Interfering.substances

    Introduction Interfering Substances Glucose Interferences: The Nova StatStrip Xpress Glucose Hospital Meter exhibits no interference from the following substances up to the following concentration levels: Substances Conc Substances Conc mg/dL(mmol/L) mg/dL(mmol/L) D(+) Maltose 240.0 (6.66) Acetaminophen 10.0 (0.66) D(+) Maltotetraose 240.0 (3.6) Ascorbic Acid 10.0...

  • Page 20: Operation.overview

    Introduction Operation Overview • To perform a test, the operator inserts a test strip into the test strip port. Touch the end of the strip to a drop of blood, QC solution, or linearity solution. The results are obtained in 6 seconds. •...

  • Page 21: Meter.sleep/Wakeup

    Introduction • A coin-size battery provides power to operate the meter. The battery provides sufficient power to operate for approximately 600 tests. A low-battery warning on the meter display alerts the operator to change the battery. An auto sleep feature conserves power when the meter is not in use.
  • Page 22 Introduction If the meter goes into sleep mode, the following conditions should be expected: • If blanking occurs when a Patient Result screen is displaying, the result is automatically saved. • If the currently displayed screen is a Setup screen, any unconfirmed input data or menu selection are discarded prior to blanking.

  • Page 23: Setup

    Setup This section describes how to setup the Nova StatStrip Xpress Glucose Hospital Meter. The operator can set the meter for local time and date, have the beeper On or Off, enable the sample counter, and set the date display format. Installing the Battery (Replacing) The meter is powered by a single 3V coin cell battery, 2450.
  • Page 24 Setup 3. Replace the battery cover. All segments flash 3 times. The software version and the default date and time will appear for 3 seconds then the screen will go blank. CAUTION: Upon installing the battery, the meter software version is displayed for 3 seconds. Software versions may be numeric (example 5.0); therefore, please exercise caution to ensure the software version is not reported as a glucose result.

  • Page 25: Set.the.time

    Setup 4. Go to setup to configure the meter. Set the Time 1. Press the MODE button for longer than 3 seconds. The meter if in Sleep Mode wakes up and enters the SETUP Mode.
  • Page 26 Setup 2. Select the hour (flashing) format: either 12 Hr or 24 Hr. Press the Right/Left Arrow buttons to toggle between the 2 time format options. 3. Press the MODE button to accept the Hour Format. 4. The meter displays the current time or the default time with the hour digits flashing.
  • Page 27 Setup 8. Press the MODE button to accept the displayed Min- utes choice.

  • Page 28: Set.date.format

    Setup Set Date Format 1. Next set the date format. The display is 1-31 2007 or 31.01.2007. 2. You can choose to have the date displayed as DD.MM or MM-DD. Press the Right/Left Arrow buttons to toggle between DD.MM or MM-DD. 3.
  • Page 29 Setup 4. The year should be flashing. Press the Right/Left Arrow buttons to select the current year. 5. Press the MODE button to accept the displayed Year.
  • Page 30 Setup 6. The month should be flashing. Press the Right/ Left Arrow buttons to scroll through the 12 months (1 to 12). 7. Press the MODE button to accept the displayed Month.
  • Page 31 Setup 8. The day should be flashing. Press the Right/Left Ar- buttons to scroll through the days of the month. 9. Press the MODE button to scroll the displayed Day.

  • Page 32: Beeper.on.or.off

    Setup Beeper On or Off 1. Press the Right/Left Arrow buttons to toggle between Beeper ON or OFF (flashing). 2. Press the MODE button to accept the displayed ON or OFF.
  • Page 33 Setup End is displayed with the entered date and time. Press the Mode button for 1.5 seconds to exit Setup or the meter will time out in 1 minute.

  • Page 34: Testing:.qc/Linearity/Proficiency/Blood.samples

    External controls materials are available from Nova Biomedical for verifying the integrity of the Nova StatStrip Xpress Glucose Hospital Meter. These StatStrip Glucose Control Solutions consist of 3 levels of ready-to-use liquid controls. They are formulated at clinically relevant levels.

  • Page 35: Statstrip.glucose.control.solution

    Only the Nova StatStrip Glucose Control Solutions are rec- ommended for use with the Nova StatStrip Xpress Glucose Meter and the Nova StatStrip Glucose Test Strips. Ranges for the Nova StatStrip Xpress Glucose Meter using other commercially available glucose controls have not been established and may give erroneous results.
  • Page 36 Testing a Quality Control Solution • Each new operator • Before using the StatStrip Meter for the first time • If a patient test has been repeated and the blood glucose results are still lower or higher than expected • If there are other indications that the system is not working properly •...

  • Page 37: Testing.a.quality.control.solution

    Testing a Quality Control Solution Good Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any question about the test system integrity or operator technique. This section describes how to run QC (Quality Control), Linearity Solution, Proficiency Solution, and blood samples.
  • Page 38 Testing a Quality Control Solution 2. Identify the sample as a Control; use the Left or Right button to find the desired control level: C1, C2, or C3. 3. Touch the end of the test strip to a drop of control solution until the test strip fills and the meter beeps.
  • Page 39 Testing a Quality Control Solution 4. Glucose quality control test results are available on- screen in 6 seconds. Result Result Displayed Displayed in in mg/dL mmol/L 5. There is one long beep when the results are ready. There are 3 short beeps if test results are outside the measurement range of the test strip.

  • Page 40: Testing.a.blood.sample

    Testing a Blood Sample NOTE: Do not test patient samples until control solution test results are within expected range. 1. Insert a test strip into the meter. Verify that all segments of the screen display. If the display is incomplete, discontinue use for diagnostic testing. Then a flashing blood drop will display.
  • Page 41 Testing a Blood Sample 2. Wash patient's hand with water then dry thoroughly. Alternatively, use alcohol pads to clean area; dry thoroughly after cleaning. 3. Holding hand down- ward, massage finger with thumb toward tip to stimulate blood flow. 4. Use a lancet to puncture the finger.
  • Page 42 Testing a Blood Sample 5. Squeeze the finger to form a drop of blood. 6. When the blood drop appears, touch the end of the test strip to the blood drop until the test strip fills and the meter beeps. 7.
  • Page 43 Testing a Blood Sample Result in mg/dL Result in mmol/L 8. There is one long beep when the results are ready. There are 3 short beeps if test results are outside the range of the test strip.
  • Page 44 Testing a Blood Sample If result is LO (less than the measurement range) or Hi (greater than the measurement range) repeat the test. HI in mg/dL LO in mmol/L NOTE: Test results are automatically saved. If no activity for 1 minute, the meter will time-out: screen goes blank.

  • Page 45: Testing.a.linearity/Proficiency.solution

    Testing a Linearity/Proficiency Solution For CLIA Moderate Settings only: This section describes how to perform Linearity tests with the StatStrip Xpress Glucose Hospital Meter. There are 5 levels in the StatStrip Glucose Linearity kit. Refer to the StatStrip Linearity Kit package insert sheet for complete instructions, indications, precau- tions, and limitations of the system.
  • Page 46 Testing a Linearity/Proficiency Solution 2. Touch the end of the test strip to a drop of linearity solution or proficiency solution until the test strip fills and the meter beeps. NOTE: LinearitylProficiency test results are stored in memory as a blood sample. NOTE: A quick beep sounds when sufficient linearity/ proficiency solution has been added to the test strip. 3. Linearity or proficiency test results are available on- screen in 6 seconds.
  • Page 47 Testing a Linearity/Proficiency Solution Result in mg/dL Result in mmol/L 4. There is one long beep when the results are ready. There are 3 short beeps if test results are outside the measurement range of the test strip.

  • Page 48: Reviewing.test.results

    Reviewing Test Results The meter is able to store up to 400 test results. 1. To review test results, press the Mode button once for less than 3 seconds. 2. If there are no results in memory, the screen displays - - - on the mem (memory) screen.

  • Page 49: Deleting.stored.test.results

    Deleting Stored Test Results You can delete all stored test and QC results. Proceed as follows to delete all results: 1. Press the Mode button once to display the number of stored test results. 2. Press the Right and Left arrow button simultaneously for longer than 3 seconds.
  • Page 50 Deleting Stored Test Results 4. When the Screen displays dELEtE (flashing), press the left and right buttons simultaneously for greater than 3 seconds. All results are deleted. The screen will display OK and dELEtEd as shown below. 5. To exit without deleting results. press the MODE button once.

  • Page 51: Troubleshooting

    Troubleshooting This section describes Battery status, Error Codes, and Ac- tions for the Nova StatStrip Xpress Glucose Hospital Meter. Battery Check The battery provides sufficient power to operate for approximately 600 tests. A battery low warning will alert the user to replace the battery. Test results are stored in non-...
  • Page 52 Troubleshooting How to view the battery status of the meter: • Insert a test strip to the meter when it is turned off. • All segments will display for 2 seconds. • Battery is OK: a flashing blood drop appears at the lower left corner of the screen.
  • Page 53 Troubleshooting • Battery is Low: a flashing blood drop and battery icon appear at the lower left corner of the screen: battery charge sufficient for up to 10 tests. Continue with testing as usual. Battery icon remains on the screen. Battery Icon Flashing Blood Drop...
  • Page 54 Troubleshooting • Battery is very Low: battery icon at the lower left corner of the screen: battery charge insufficient for testing. Meter will not operate and battery icon disappears when the test strip is removed. Replace the battery. CAUTION: Attempts to perform Battery Icon glucose testing with a low battery could result in the software rebooting.

  • Page 55: Error.codes

    Troubleshooting Error Codes There are 8 Error Codes to inform you of problems with the meter. This section provides action procedures when these Error Codes are displayed. The error code displays after the test strip is inserted and the all segments screen displays for 2 seconds.
  • Page 56 Troubleshooting E1 System Hardware Error A system hardware error has been detected. Action: Perform the test again. If you get the same error, call Nova Technical Support. E2 Operating Temperature Error The Meter temperature is outside of the range for testing. Action: Move the meter to an area where the temperature is acceptable (59°-104°F or 15°-40°C), allow meter to adjust to the...
  • Page 57 Troubleshooting E3 Used Strip Error The test strip was previously used. Action: Repeat the test with a new test strip. If the error persists, perform the test using an alternate test strip vial or alternate method. E4 Short Sample Error An insufficient sample volume (Control or blood) was drawn into the test strip.
  • Page 58 Troubleshooting E5 Strip Not Recognized Error The test strip is not recognized. Action: Repeat the test with a new test strip. If the error persists, perform the test using an alternate test strip vial or alternate method. E8 Bad Strip Error The test strip is defective or bad.

  • Page 59: Appendix

    Troubleshooting E9 Bad Sample Error A problem was detected with the sample. Action: Repeat the test with a new test strip. If the error persists, perform the test using an alternate test strip vial or alternate method. Appendix The Appendix includes solution and reagent specifications, accuracy and precision, consumable list, reference informa- tion, and warranty.

  • Page 60: A.1.Specifications

    Appendix A.1 Specifications Tests Measured Blood Glucose (referred to Plasma Values) Glucose Methodology Enzyme, Amperometric Glucose Test Results mg/dL, mmol/L Sample Type Whole blood Glucose Test Range 10 to 600 mg/dL 0.6 to 33.3 mmol/L Test Time 6 seconds Test Strip Volumes 1.2 µL Memory storage 400 Tests...

  • Page 61: A.2.Reference.values

    Appendix Operating Ranges: Temperature 59° to 104°F (15° to 40°C) Humidity 10% to 90% relative humidity Altitude 15,000 ft (4572 meters) Hematocrit 20% to 65% Weight 2.65 oz (75 g) Size 3.6x2.3x0.9 in(91.4x58.4x22.9 mm) A.2 Reference Values Each laboratory should establish and maintain its own reference value.

  • Page 62: A.3.Glucose.methodology

    Appendix A.3 Glucose Methodology The glucose measurement is based on the following methodology: 1. Glucose + Enzymes(oxidized form) ––– > Gluconic Acid + Enzymes(reduced form) 2. Enzymes(reduced form) + Ferricyanide –– > Enzymes(oxidized form) + Ferrocyanide 3. Ferrocyanide ————— > Ferricyanide Electrode The current generated at the electrode is proportional to the glucose concentration of the sample.

  • Page 63: A.4.Quality.control.solution

    Appendix A.4 Quality Control Solution QC Solutions Levels 1, 2, 3 Linearity Solutions Levels 1, 2, 3, 4, 5 A.5 Chemistry Measurement The typical imprecision for glucose both for within-run and day-to-day Glucose Levels Glucose Levels (mg/dL) (mmol/L) 22.2 33.3...

  • Page 64: A.6.Ordering.information

    Appendix A.6 Ordering Information Supplies and parts for the Nova StatStrip Xpress Glucose Hospital Meter are available from Nova Biomedical. DESCRIPTION ............Instructions for Use Manual ........43306 Quick Reference Guide .......... 44398 StatStrip Xpress Glucose Meter (mg/dL) ....43404 StatStrip Xpress Glucose Meter (mmol/L) .....

  • Page 65: A.7.Cleaning.and.care

    Appendix A.7 Cleaning and Care The meters should never be immersed in any cleaning agent. Always apply the cleaning agent to a soft cloth to wipe the meter surface. Once complete, immediately dry thoroughly. When cleaning the meter, please follow the guidelines listed below: •...
  • Page 66 Appendix CAUTION: DO NOT immerse the meter or hold the meter under running water. DO NOT spray the meter with a disinfectant solution. CAUTION: Do Not attempt to open the meter to make any repairs. Your warranty and all claims will be void! Only Nova Biomedical authorized service personnel can repair the meter. Call Nova Biomedical or an authorized dealer if the meter needs to be repaired or checked.

  • Page 67: A.8.Results.of.clia.waiver.study

    Medical Surgical unit; Site2: Cardiac, Pediatric, Oncol- ogy unit; and Site3: Progressive care unit), and Northeast region (Site4: Nova Biomedical, Waltham, MA). There were a total of 24 operators distributed as follows; site1 through site 4 had 3, 4, 5, and 12 operators, respectively. The study involved running 525 specimens (110 subjects;...
  • Page 68 Nova StatStrip Xpress that were as accurate as those obtained by trained operators using the comparative methods. The crite- ria for success for accuracy required that at least 95% of the results fall within the allowable total error (ATE) zone, defined as ±...
  • Page 69 Results of CLIA Waiver Study (continued) The results of the study for venous and arterial samples were following: Range of Total number Number of Percent of Dade values of samples samples samples (mg/dL) within of ATE within of ATE 17 to 97 100% 97.1 to 114 100%...
  • Page 70 Results of CLIA Waiver Study (continued) The scatter plot of the study results for arterial and venous sam- ples with ATE and LER zones is presented by the figure below:...
  • Page 71 Results of CLIA Waiver Study (continued) The descriptive statistics of the differences between Dade glucose and Nova StatStrip results of arterial and venous samples are presented by the table below: Range of Average 2.5th percen- 97.5th percen- Dade values Difference tile of relative tile of relative (mg/dL)
  • Page 72 Results of CLIA Waiver Study (continued) The results of the study for capillary samples were following: Range of Total Number of Percent of YSI values number of samples samples (mg/dL) samples within of within of <75 100% 75 - 97 94.1% 97.1 to 114 97.9%...
  • Page 73 Results of CLIA Waiver Study (continued) The percentage of the capillary samples over the entire range that fall within the ATE zone was 96.8% (153/158) with a lower one-sided 95% confidence bound of 93.6%. In the study, no samples were in the LER zone (0% with an upper bound of 95% confidence interval of 1.7%).
  • Page 74 Results of CLIA Waiver Study (continued) The descriptive statistics of the differences between YSI glucose and Nova StatStrip results of capillary samples are presented by the table below: Range of Average 2.5th 97.5th Dade values Difference percentile percentile (mg/dL) of relative of relative differences differences...
  • Page 75 Results of CLIA Waiver Study (continued) Please note that the upper one-sided 95% confidence bound for capillary was 1.7% due to small sample size. The results of the study for neonatal capillary samples were following: Range of Vi- Total Number of Percent of tros values number of...
  • Page 76 Results of CLIA Waiver Study (continued) The percentage of the neonatal capillary samples over the entire range that fall within the ATE zone was 100% (100/100) with a lower one-sided 95% confidence bound (score method) of 97.4%. In the study, no samples were in the LER zone (0% with an upper one-sided 95% confidence bound of 2.6%).
  • Page 77 Results of CLIA Waiver Study (continued) The scatter plot of the study results for neonatal capillary samples with ATE and LER zones is presented by the figure: The descriptive statistics of the dif- ferences between Vitros (Johnson & Johnson) glucose and Nova StatStrip results of neonatal capillary samples are presented by the next table:...
  • Page 78 Results of CLIA Waiver Study (continued) Range of Average Dif- 2.5th percen- 97.5th percen- Dade values ference tile of relative tile of relative (mg/dL) differences differences 18 to 75 -3 mg/dL -12.75 mg/dL 5 mg/dL 75.1 to 97 -1.3 % -14.9 %* 9.1 % 97.1 to 114...

  • Page 79: Warranty

    Warranty Subject to the exclusions and upon the conditions specified below, Nova Biomedical or the authorized Nova Biomedical distributor warrants that he will correct free of all charges including labor, either by repair, or at his election, by replacement, any part of an instrument which fails after delivery to the customer because of defective material or workmanship.
  • Page 80 1. The date printed on the package label has been exceeded. 2. Non-Nova Biomedical reagents or controls are used, as follows: Nova Bio- medical will not be responsible for any warranty on Nova StatStrip Xpress Glucose Hospital Meter if used in conjunction with and are adversely affected by reagents, controls, or other material not manufactured by Nova but which contact or affect such parts.
  • Page 81 DAMAGES IN CONNECTION WITH THE SALE OR FURNISHING OF GOODS OR PARTS, THEIR DESIGN, SUITABILITY FOR USE, INSTAL- LATION OR OPERATION. NOVA BIOMEDICAL WILL IN NO EVENT BE LIABLE FOR ANY SPECIAL OR CONSEQUENTIAL DAMAGES WHAT- SOEVER, AND OUR LIABILITY UNDER NO CIRCUMSTANCES WILL EXCEED THE CONTRACT PRICE FOR THE GOODS FOR WHICH THE LIABILITY IS CLAIMED.
  • Page 83 Aston Lane South, Runcorn Cheshire, WA7 3FY UK For technical assistance outside the United States, call your local Nova subsidiary or authorized distributor. Nova Biomedical Canada, Ltd. Nova Biomedical UK Nova Biomedical GesmbH 17 - 2900 Argentia Road Innovation House...
  • Page 84 Fax: 1-781-893-6998 U.S.A. Web: www.novabiomedical.com U.S. Patent Nos. 6,258,229; 6,837,976; and 6,942,770 CA 2,375,089; 2,375,092 Made in the USA by Nova Biomedical Corporation StatStrip Xpress is a registered trademark of Nova Biomedical. ® Copyright 2012 Nova Biomedical Corporation 43306F 12.2012...

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