FDA Registration
Active
🇺🇸 United States
Bio-Rad Laboratories Inc.
Reg #: 2016706
·
FEI: 2016706
·
Expires 2026
Products
20
Proprietary Names
143
Establishment Types
3
Classifications
20
Registration Details
- Registration Name
- Bio-Rad Laboratories Inc.
- Registration Number
- 2016706
- FEI Number
- 2016706
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9500 Jeronimo Rd
- City
- IRVINE
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K003030
Owner / Operator
- Firm Name
- Bio-Rad Laboratories, Inc.
- Operator Number
- 9929003
- Address
- 4000 Alfred Nobel Drive, --
- City
- Hercules
- State
- CA
- Postal Code
- 94547
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2008-01-28 |
| Mixture, Hematology Quality Control | JPK | Class 2 | Hematology | No | 2010-08-03 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2008-06-09 |
| Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | DHN | Class 2 | Immunology | No | 2008-01-28 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-03-01 |
| Controls For Blood-Gases, (Assayed And Unassayed) | JJS | Class 1 | Clinical Chemistry | No | 2008-06-04 |
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2008-04-11 |
| Antinuclear Antibody, Antigen, Control | LKJ | Class 2 | Immunology | No | 2008-01-28 |
| Control, Hemoglobin, Abnormal | JCM | Class 2 | Hematology | No | 2008-06-20 |
| Urinalysis Controls (Assayed And Unassayed) | JJW | Class 1 | Clinical Chemistry | No | 2008-06-20 |
| Calibrator, Multi-Analyte Mixture | JIX | Class 2 | Clinical Chemistry | No | 2014-05-19 |
| Control, Cell Counter, Normal And Abnormal | JCN | Class 2 | Hematology | No | 2008-01-28 |
| Anti-Sm Antibody, Antigen And Control | LKP | Class 2 | Immunology | No | 2008-01-28 |
| Kit, Quality Control For Blood Banking Reagents | KSF | Class 2 | Hematology | No | 2008-01-29 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2008-04-11 |
| Enzyme Controls (Assayed And Unassayed) | JJT | Class 1 | Clinical Chemistry | No | 2008-06-23 |
| Heavy Metals Control Materials | DIE | Class 1 | Clinical Toxicology | No | 2008-04-11 |
| Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | PMN | Class 2 | Microbiology | No | 2016-04-19 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2008-04-11 |
| Kit, Test (Donors), For Bloodborne Pathogen | MYZ | Class 2 | Unknown | No | 2008-01-29 |
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)
Liquichek Pediatric Control
Liquichek Homocysteine Control
InteliQ Homocysteine Control
Liquichek Cardiac Markers Plus Control LT (Vista)
VIROTROL I
Lyphochek Urine Bone Markers Control
Liquichek Urine Toxicology Control, Confirmatory C1
Liquichek Autoimmune Control, Anti-Mitochondrial
Liquichek Reticulocyte Control (A-1)
Liquichek Cardiac Troponins Control
Liquichek ANA Control, Homogeneous Positive
Liquichek Immunoassay Plus Control
InteliQ Immunoassay Plus Control
Amplichek II
Liquichek Urine Toxicology Control, Screen - S1S and S2S
Lyphochek Whole Blood Immunosuppressant Control
Lyphochek Maternal Serum Control
Liquichek Rheumatoid Factor Control
Liquichek Pediatric Control (Vista)
Liquichek Opiate Control
Liquichek Qualitative Urine Toxicology Control
Liquichek Immunology Control
InteliQ Immunology Control
Liquichek Urinalysis Control
Lyphochek Hemostasis Control
Liquichek Autoimmune Control, Anti-RNP
Liquichek Urine Chemistry Control (2.5 mL vials) and Liquichek Urine Chemistry Control (Tubes)
InteliQ Urine Chemistry Control
Liquichek Immunoassay Plus Control (Vista)
VIROTROL IV
Lyphochek Allergen sIgE Control, Negative
Lyphochek Allergen sIgE Control, Panel A
Lyphochek Anemia Control
VIROTROL HIV-2
Lyphochek Urine Metals Control
Liquichek Blood Gas Plus EGL Control
Lyphochek Tumor Marker Plus Control
Liquichek Reticulocyte Control (S)
Lyphochek Fertility Control Serum
Lyphochek Urine Toxicology Control
VIROCLEAR
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)