Bio-Rad Laboratories, Inc.

Clinical Diagnostics Group

4000 Alfred Nobel Drive

Hercules, California 94547

www.bio-rad.com

Phone number and To Place an Order: 1-800-2-BIORAD (1-800-224-6723)

General email for information request: diagcs@bio-rad.com

CORPORATE DESCRIPTION

Bio-Rad is the number one specialty diagnostics company with leadership positions in quality control management, diabetes monitoring, blood virus and autoimmune disorders testing.

 

Bio-Rad serves more than 70,000 research, industry and clinical laboratories around the globe. It is world renowned within its core industry segments with customers in hospitals, universities, research institutions, microbiological food and environmental inspection agencies, pharmacological and biological research, and private industry laboratories.

 

Bio-Rad offers the following quality control products and rapid HbA1c and Toxicology tests for
point of care settings.

• Meter Trax

• qUAntify Control

• Liquichek Qualitative Urine Toxicology Control

• TOX/See Rapid Urine Drug Screen Tests

• Micromat II Hemoglobin A1c Instrument

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PRODUCTS

Meter Trax^TM

Product Description

Meter Trax^TM  is a whole blood quality control that can be used for glucose, hemoglobin and hematocrit testing on point of care instruments. May be used as part of a laboratory program to assess operator competence.

Product Features

• Human whole blood based control

• Glucose and hemoglobin stable for 31 days at 2–25ºC after opening

• Hematocrit stable for 31 days at 2–8ºC after opening

• 6 month shelf life at 2–8ºC

• Peer group reports available

Claimed Analytes

 

Glucose

• Value assigned for Abbott, Bayer, i-Sens, LifeScan and Roche meters

Hematocrit

• Value assigned for i-STAT^®, Separation Technologies, StatSpin^® and centrifuge methods

Hemoglobin

• Value assigned for HemoCue^® and manual methods

Refer to the package insert of currently available lots for specific analyte and stability claims

 

Configuration and Catalog number

 

 

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qUAntify^® Control

 

Product Description

qUAntify^®  Control is designed to monitor the performance of urine dipstick testing. The control is available in 12 mL
ready-to-use dropper bottles.

 

Product Features

• Liquid

• Designed for dipstick testing

• 2 year shelf life at 2–8°C

• 31 day open-vial stability at 2–25ºC

• Color-coded peer group reports available

Claimed Analytes

• Albumin                                     

• Glucose                 

• Pregnancy (hCG)

• Albumin-to- Creatinine Ratio         

• Hemoglobin             

• Protein

• Ascorbic Acid                    

• Ketones                 

• Protein-to-Creatinine Ratio

• Bilirubin                                     

• Leukocytes             

• Specific Gravity

• Blood                                        

• Nitrite           

• Urobilinogen

• Creatinine                                  

• pH     

Refer to the package insert of currently available lots for specific analyte and stability claims

 

Configuration and Catalog number

975          qUAntify^®  Control, Bilevel (3 each of 2 levels) ……..............6 x 12 mL

975x         qUAntify^®  Control, Bilevel MiniPak (1 each of 2 levels)……2 x 12 mL

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Liquichek^™ Qualitative Urine Toxicology Control

Product Description

Liquichek^TM  Qualitative Urine Toxicology Control is a liquid control designed for use with qualitative rapid urine drug screen panels, including Point of Care (POC) Drugs-of-Abuse (DOA) test kits like Bio-Rad TOX/See^TM, Biosite Triage®, American Bio Medica Rapid One® (for new analyte Oxycodone) and other popular test kits. The package insert includes qualitative results (+/-) for popular kits and recovery values by gas chromatography (GC) and other quantitative methods.

Product Features

• Unbiased assessment of your test procedures

• Negative and positive levels

• Human urine based control

• 3 year shelf life at 2–8°C

• 30 day open-vial stability at 2–25°C

Refer to the package insert of currently available lots for specific analyte and stability claims

Configuration and Catalog number

 

 

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TOX/See^TM Rapid Urine Drug Screen Tests

Product Description

TOX/See™ is a 1-step, hand-held, point-of-care device for the qualitative detection of drug or drug metabolites in human urine.

The TOX/See^TM device can detect up to nine of the most commonly abused drugs in 3 to 8 minutes and requires only a few drops of urine. Each TOX/See^TM cassette is individually packaged to maximize convenience and ease of use. TOX/See^TM features integrated test controls, easy-to-read results, and an 18-month shelf life at room temperature. The completed test card can be photocopied and archived for health and legal records.

The straightforward test protocol is designed for use by all levels of staff in hospitals, emergency departments, correctional facilities, juvenile facilities, police departments, workplaces, and recovery and rehabilitation programs.

Product Features

• Comprehensive—Tests for as many as 9 drugs per cassette

• Efficient—One-step test protocol

• Fast—Results in as few as 3 minutes

Configuration and Catalog number
194-5223          TOX/See Multi-Drug Screen Panel,

(PCP/BAR/AMP/COC/MET/TCA/OPI [MOR300]/THC/BZO), 25 tests

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Micromat^TM II Hemoglobin A1c Instrument

Product Description

Glycohemoglobin Testing for Healthcare Professionals

Easy-to-use, with laboratory accuracy and precision, Bio-Rad's Micromat™ II HbA1c Instrument enables the low-volume laboratory, clinic or physician's office to report HbA1c results during the patient visit. This eliminates long delays between patient visits and HbA1c test result availability.

Enabling face-to-face dialog for rapid treatment intervention, the immediate results provided by the Micromat™ II supply the healthcare provider with an important tool to improve patient care and more effectively manage patient needs.

Product Features

• CLIA waived* for US market

• CE Marked for European market

• Easy-to-use

• Simple, icon-guided test procedure

• Self-contained cartridge

• 10 µL finger stick specimen

• Room temperature cartridge storage (2–25°C)

• Laboratory precision, ‹4% CV

• Calibrated to the DCCT

• No interference from hemoglobin variants

• Immediate results: 5 minutes

• Results available during patient visit

• Proven methodology

• NGSP certified to be traceable to the DCCT reference method

* 510(k) cleared for prescription home use and, accordingly, is CLIA waived

Configuration and Catalog number

CLIA Waived Product

• 280-0016          CLIA Waived Micromat II HbA1c Instrument with Power Supply, 1 unit

• 280-0007          CLIA Waived Micromat II Control Cartridge, 1 unit

• 280-0008          CLIA Waived Micromat II HbA1c Test Cartridges, 12 tests

CE Marked Product

• 280-0016EX          CE Marked Micromat II HbA1c Instrument with Power Supply, 1 unit

• 208-0007EX          CE Marked Micromat II Control Cartridge, 1 unit

• 280-0008EX          CE Marked Micromat II HbA1c Test Cartridges, 12 tests