Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2915274

FEI Number

2915274

Entity Name

Bio-Rad Laboratories, Inc.

City/State/Country

Hercules, CA, US

Establishment Address

4000 Alfred Nobel Drive, Hercules, CA 94547, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bio-Rad Laboratories, Inc. (Owner Number: 9929003)

Owner / Operator Contact Address

4000 Alfred Nobel Drive, --, Hercules, CA 94547, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090699

PMA Number

N/A

All Registered Proprietary Names

TOX/See Drug Screen Test-BUP Bio-Rad DGP-A and DGP-G VARIANT II with CDM 4 BioPlex Vasculitis Kit ANA Screen with MDSS VARIANT II Turbo Hemoglobin Testing System BioPlex HSV-1 & HSV-2 Kit TOX/See Drug Screen Test VARIANT II TURBO with CDM 4 Kallestad Anti-Neutrophil Cytoplasmic Antibodies (ANCA) Test System BioPLex 2200 System TOX/See Drug Screen Test-PCP BioPlex 2200 Celiac IgA and IgG BioPlex 2200 MMRV IgG TOX/See Drug Screen Test-COC D-10 Hemoglobin A1c Program D-10 Hemoglobin Testing System PhD lx System PhD lx Workstation PhD System BioPlex 2200 25-OH Vitamin D BioPlex 2200 Lyme Total D-100 Hemoglobin Testing System Monofluo Pneumocystis IFA, MONOFLUO Pneumocystis jirovecii IFA VARIANTnbs with GDM 3 Autoimmune EIA Anti-Scl-70 VARIANT II TURBO Link Hemoglobin Testing System VARIANT II TURBO Hemoglobin Testing System VARIANTnbs Newborn Screening System VARIANTnbs Sickle Cell Program ENZYME IMMUNOASSAY ANT ENZYME IMMUNOASSAY ANTINUCLEA Autoimmune EIA ANA Screening Test Kit (96 Test) DiaSorin EIA ANA Screen Test Kit Autoimmune EIA ANA Screening Test Kit (576 Test) Meridian EIA ANA Screen Test Kit Quest EIA ANA Screen Test Kit Trinity EIA ANA Screen Test Kit Autoimmune EIA Anti-dsDNA Kallestad Mouse Stomach Kidney Slide QXDx Universal Kit for ddPCR System QXDx Supermix Pack QXDx Droplet Reader Oil Pack QXDx Consumable Pack Kallestad HEp-2 Slide BioPlex 2200 EBV IgG Kit Autoimmune EIA Anti-Jo-1 Autoimmune EIA ANA-6 Profile BioPlex 2200 ToRC IgM Autoimmune EIA Anti-Centromere VARIANT II TURBO LINK VARIANT II Hemoglobin Testing Sys. VARIANT II HbA1c Program (New) BIOPLEX 2200 EBV IGM PANEL ON TOX/See Drug Screen Test-MTD BioPlex 2200 HSV-1 & HSV-2 IgG BioPlex 2200 APLS IgG and IgA kit BioPlex 2200 APLS IgM VMA by HPLC TOX/See Drug Screen Test-AMP BioPlex 2200 MMRV IgG TOX/See Drug Screen Test-MDMA BioPlex 2200 ANA Screen with MDSS TOX/See Drug Screen Test-BZO BioPlex 2200 Anti-CCP Kit Kallestad Anti-Thyroglobulin (Tg) Microplate EIA QXDx Automated Droplet Generator IVD QX600Dx Droplet Reader QXDx AutoDG Supermix Pack B QXDX Droplet Reader Kallestad Crithidia (nDNA) BioPlex ToRC IgG Kit TOX/See Drug Screen Test-TCA TOX/See Drug Screen Test-MET Autoimmune EIA Anti-SS-A/Ro BioPlex 2200 Anti-CCP Kit VARIANT II TURBO Hb Testing System VARIANT II TURBO HbA1c Program Autoimmune EIA ENA Plus Hemoglobin Variants System on the Newborn Hemoglobin System with GDM and HbReview software Accessory Component for the PhD lx IFA/ EIA Processing and PhD Testing Sytems PR4100 QXDx Droplet Reader QXDx BCR-ABL %IS Kit QXDx Automated Droplet Generator Autoimmune EIA Anti-SS-B/La BioPlex 2200 HIV Ag-Ab Plasma Catecholamines by HPLC Kallestad Anti-CCP II Microplate EIA VARIANT II TURBO Link HbA1c Program VARIANT II TURBO HbA1c Kit - 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-12-20
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2014-06-02
JPD	Hemoglobin A2 Quantitation	Hematology	Class 2	864.7400	2008-04-17
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-04-17
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-01-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-01-04
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2010-01-04
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	Class 2	866.5660	2010-01-04
NVI	Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease	Clinical Toxicology	Class 2	862.3100	2010-01-04
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2014-11-12
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2010-01-04
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2010-01-04
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2014-11-03
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2014-11-03
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2014-11-03
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2014-11-03
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2014-11-03
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2014-11-03
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2014-11-03
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2014-11-03
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2014-11-03
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2014-11-03
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2014-11-03
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-04-17
LDM	Instrumentation, High Pressure Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2008-04-17
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-12-20
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2016-02-08
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-12-20
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2013-10-31
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-10-31
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2013-10-31
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-10-31
OPL	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus	Microbiology	Class 2	866.3510	2010-12-01
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	2010-12-01
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2010-12-01
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2010-12-01
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-12-20
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2016-12-09
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2011-11-23
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2018-06-28
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2019-03-28
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2015-12-16
LYF	Pneumocystis Carinii	Microbiology	Class 2	866.3780	2024-12-06
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2008-05-05
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2008-04-17
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2015-06-10
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2015-06-10
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	1994-10-03
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2006-04-25
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2006-04-25
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2006-04-25
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2024-12-06
PFT	Reagents For Molecular Diagnostic Test Systems	Clinical Chemistry	Class 1	862.3800	2016-06-23
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2024-12-06
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-02-12
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2008-04-17
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2010-09-03
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-05-25
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Microbiology	Class 2	866.3175	2017-05-25
PUQ	Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm	Microbiology	Class 2	866.3510	2017-05-25
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2017-05-25
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2017-05-25
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2017-05-25
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2008-04-17
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2007-05-16
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2007-05-16
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2007-03-07
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2007-03-07
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-12-20
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-07-17
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-07-17
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2012-07-17
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2012-07-17
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2012-07-17
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2012-07-17
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-07-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-07-17
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-10-31
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2013-10-31
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2013-10-31
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-10-31
CDF	Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin	Clinical Chemistry	Class 1	862.1795	2008-04-17
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-12-20
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2011-12-29
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2011-12-29
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	2011-12-29
OPL	Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus	Microbiology	Class 2	866.3510	2011-12-29
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2012-12-20
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2012-07-17
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-12-20
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2011-12-29
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2012-12-20
PHG	Droplet Digital Pcr System	Clinical Chemistry	Class 2	862.2570	2026-06-01
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2024-12-06
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-01-04
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-01-04
OMI	Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv	Microbiology	Class 2	866.3510	2010-01-04
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2012-12-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2012-12-20
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2008-04-17
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2010-12-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-12-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-12-01
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2008-04-17
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2006-04-25
GKA	Abnormal Hemoglobin Quantitation	Hematology	Class 2	864.7415	2017-09-19
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2013-04-30
PHG	Droplet Digital Pcr System	Clinical Chemistry	Class 2	862.2570	2019-05-28
OYX	Bcr/Abl1 Monitoring Test	Medical Genetics	Class 2	866.6060	2019-05-28
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2008-04-17
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2015-08-14
CHQ	Chromatographic/Fluorometric Method, Catecholamines	Clinical Chemistry	Class 1	862.1165	2008-04-16
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2012-12-20
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2014-12-11
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2009-07-30

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Bio-Rad Laboratories, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3032023483	Bio-Rad Laboratories (S) Pte Ltd	Singapore South West, SG
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3006421415	Bio-Rad Laboratories (Singapore) Pte. Ltd.	Singapore Central Singapore, SG
2016706	Bio-Rad Laboratories Inc.	IRVINE, CA, US
3010127294	Bio-Rad Laboratories Inc.	Irvine, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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K112310	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST,OPIATE TEST	2011-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012	Bio-Rad Laboratories, Inc.	2	D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0022-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0023-2012	Bio-Rad Laboratories, Inc.	2	VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0024-2012	Bio-Rad Laboratories, Inc.	2	VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0025-2012	Bio-Rad Laboratories, Inc.	2	VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0026-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0027-2012	Bio-Rad Laboratories, Inc.	2	VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the determination of Hemoglobin A1c in human whole blood. Contents: 1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buffer 2. Elution Buffer B, 1 x 2100 mL Bis-Tris Phosphate Buffer 3. Wash/Diluent Solution, 1 x 2500 mL, Deionized water 4. Cartridge set - 2 cations exchange Analytical Cartridges, 4 cation exchange guard cartridges 5. CD-ROM 1, CD Rom with program parameters 6. Calibrator/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL deionized water. 7. Whole Blood Primer, 6 x 1 mL, Lyophilized human red blood cell hemolysate with preservative 8. Sample Vials, 2 x 100, Polypropylene vials with pierceable lids 9. Instruction Manual. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC) Made in United States. Bio-Rad Laboratories, Hercules, CA 94547.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2915274. Last updated year: 2026. Please use registration number 2915274 when referencing this establishment in official correspondence.