Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2016706

FEI Number

2016706

Entity Name

Bio-Rad Laboratories Inc.

City/State/Country

IRVINE, CA, US

Establishment Address

9500 Jeronimo Rd, IRVINE, CA 92618, 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

K141073

PMA Number

N/A

All Registered Proprietary Names

Lyphochek Hemoglobin A1C Linearity Set Liquichek Reticulocyte Control (X) Lyphochek Hypertension Markers Control Lyphochek Whole Blood Control Liquichek ANA Control, Centromere Positive Liquichek AMH Control Liquichek Blood Gas Plus CO-Oximeter (IL Synthesis Series) Lyphochek Drug Free Serum Liquichek Elevated CRP Control Liquichek Autoimmune Control, Anti-Scl-70 Liquichek Reticulocyte Control (A) Liquichek Tumor Marker Control InteliQ Tumor Marker Control, Liquid Assayed Multiqual Premium Liquichek Urine Toxicology Control, Screen EIA S1E and S2E Low Opiate and S1E and S2E Liquichek Hematology Control (C) Liquichek Cardiac Markers Plus Control Lyphochek Hemoglobin A2 Control Liquichek Lipids Control Liquichek Blood Gas Plus CO-Oximeter Control Liquichek Urine Toxicology Control Screen S1, S2, S3 Liquichek Blood Gas Plus E Control Liquichek Urine Toxicology Negative Control VIROTROL TORCH Liquichek Cardiac Markers Plus InteliQ Cardiac Markers Plus Control LT InteliQ Cardiac Advance Control Liquichek Cardiac Advance Control Liquichek Cardiac Markers Plus Control LT 1, 2, 3 and Low Liquichek Spinal Fluid Control (Vista) Liquid Assayed Multiqual (Vista) Lyphochek Quantitative Urine Control, Abnormal Liquichek Hematology-16T Control Quest Diagnostics Tumor Marker Liquichek Immunoassay Premium Control Quest Diagnostics Serum Chemistry Control Beckman Coulter Lyophilized Chemistry Calibrator 1 and 2 Lyphochek Therapeutic Drug Monitoring Control Liquichek Autoimmune, Anti-SS-B Liquichek Therapeutic Drug Monitoring Control (TDM) Lyphochek Immunoassay Plus Control Liquichek Hematology-16 Control Liquichek Cardiac Markers LT Control (1, 2, 3, Low ) Quest Diagnostics Immunoassay/TDM Control Liquichek Maternal Serum II Control Liquichek Maternal Serum First Trimester Control Liquichek Serum Volatiles Control Liquichek Reticulocyte Control (C) Liquichek Hematology Control (S) Liquichek Blood Gas CO-Oximeter Control (Radiometer) Liquichek Whole Blood Immunosuppressant Control Lyphochek Tumor Marker Control Liquichek Autoimmune, Anti-Sm Liquichek ANA Controls Set, Positive: Homogenous, Speckled, Centromere and Nucleolar Patterns InteliQ Specialty Immunoassay Control Liquichek Specialty Immunoassay Plus Control InteliQ Specialty Immunoassay Plus Control Liquichek Specialty Immunoassay Control Liquichek Urine Toxicology Control, S1O, S2O, S1O Low Opiate, S2O Low Opiate Lyphochek Benzo/TCA Control Set B Liquichek Immunology Control (Vista) Liquichek ToRCH Plus IgM Control Liquichek Blood Gas Control VIROTROL III Lyphochek Diabetes Control VIROTROL HIV-1 Ag Liquichek Autoimmune Control, Anti-Smooth Muscle Liquichek Ethanol/Ammonia Control InteliQ Ethanol/Ammonia Control Lyphochek Specialty Immunoassay Control Liquichek Hematology Control (A) Liquichek D-dimer Control Liquichek ANA Control, Speckled Positive Liquichek ANA Control, Mitotic Spindle, Positive Meter Trax Control Liquid Assayed Multiqual, InteliQ Assayed Muliqual Control Liquichek CK/LD Isoenzyme Control Liquichek Urine Chemistry Control Liquichek Hematology Control (X) Liquichek ANA Control, Nucleolar Positive VIROTROL II Liquichek Autoimmune Control, Anti-nDNA Liquichek Spinal Fluid Control Liquichek Ethanol/Ammonia Control (Vista) Liquichek Autoimmune Control, Anti-SS-A Liquichek Diabetes Control (171, 172, 173, 172X) InteliQ Diabetes Control (12008309, 12008310, 12008311, 12008312) Liquichek Diabetes Control (12011343, 12011344,12011345, 12011334) Liquichek Diabetes Control (12011308, 12011309,12011310, 12011331) Liquichek Microalbumin Control Lyphochek Whole Blood Metals Control Liquichek Urine Toxicology Control, Confirmatory, C2, C2 Low Opiate, C3, C3 Low Opiate, C4 Lyphochek Quantitative Urine Control, Normal Lyphochek Coagulation Control qUAntify Plus Control Quantify Advance Control qUAntify Control Liquichek Autoimmune Negative Control Lyphochek Assayed Chemistry Control Virotrol III Liquichek Tumor Marker Control (Vista)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2008-01-28
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2010-08-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-03
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-03-01
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-04
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-04-11
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-03-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2017-01-10
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-03-18
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-11-10
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2016-04-19
JCM	Control, Hemoglobin, Abnormal	Hematology	Class 2	864.7415	2008-06-20
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-20
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-09
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-04
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-29
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-25
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2011-01-12
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-20
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2011-01-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-12-16
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-03
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-05-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2016-12-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-04-11
JCN	Control, Cell Counter, Normal And Abnormal	Hematology	Class 2	864.8625	2008-01-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-03
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2015-07-16
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-01-25
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-03-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2010-08-03
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-04
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2012-09-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-09
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2008-01-28
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2016-09-12
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-04-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2012-09-19
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-04-16
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-04-11
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-04
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2008-01-29
GGM	Control, Hemoglobin	Hematology	Class 2	864.8625	2008-06-23
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2008-01-29
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-03-12
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2010-08-03
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-04-11
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-23
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2008-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-23
JJT	Enzyme Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2012-09-19
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2013-03-21
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2011-06-13
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-19
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-02-19
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-11-11
DIE	Heavy Metals Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2008-04-11
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-20
GGN	Plasma, Coagulation Control	Hematology	Class 2	864.5425	2008-06-23
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-06-04
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2008-01-28
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2008-06-23
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2011-06-13
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2014-08-11

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

Registration Number	Establishment Name	Location
3032023483	Bio-Rad Laboratories (S) Pte Ltd	Singapore South West, SG
3011926203	EXACT DIAGNOSTICS	Fort Worth, TX, US
3006421415	Bio-Rad Laboratories (Singapore) Pte. Ltd.	Singapore Central Singapore, SG
3010127294	Bio-Rad Laboratories Inc.	Irvine, CA, US
2915274	Bio-Rad Laboratories, Inc.	Hercules, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935876	Bio-Rad Laboratories, Inc.	ACCESS SPECIFIC IGE ASSAY	1994-03-11
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04

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)

Similar Registrations

Registration Number	Establishment Name	Location
2182501	R & D SYSTEMS, INC.	MINNEAPOLIS, MN, US
3004493545	RANDOX LABORATORIES LIMITED	CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
9615507	ACON BIOTECH (HANGZHOU) CO., LTD.	HANGZHOU Zhejiang, CN
2531491	ACON LABORATORIES, INC.	SAN DIEGO, CA, US
2244821	IMMUNOSTICS, INC.	Eatontown, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2016706. Last updated year: 2026. Please use registration number 2016706 when referencing this establishment in official correspondence.