Bio-Rad Laboratories (India) Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 30 |
| Class B | Low–moderate risk | 461 |
| Class C | Moderate–high risk | 271 |
| Class D (high risk) | Highest-risk devices | 150 |
CDSCO device licences
These disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the b…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI) to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the ba…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI, EUCAST, CA-SFM/EUCAST) to the antimicrobial agent. The test is performed from a calibrated inoculum of pu…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the ba…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain(CLSI,EUCAST,CA-SFM/EUCAST) to the antimicrobial agent. The test is performed from a calibrated inoculum of pure…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI, EUCAST, CA-SFM/EUCAST) to the antimicrobial agent. The test is performed from a calibrated inoculum of pu…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the ba…
IMP/IVD/2018/000032 · from FranceThese disk is used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI, EUCAST, CA-SFM/EUCAST) to the antimicrobial agent. The test is performed from a calibrated inoculum of pu…
IMP/IVD/2018/000032 · from FrancePlatelia Candida Ag Plus is a one-stage sandwich immuno-enzymatic quantitative microplate assay used to detect mannan antigen of Candida in human serum or plasma specimens. This kit can be used for screening or as an aid to the diagnosis of…
IMP/IVD/2018/000032 · from FranceAn indirect fluorescent antibody procedure for the detection and semi-quantitation of human auto-antibodies.
IMP/IVD/2020/000420 · from United StatesAn indirect fluorescent antibody procedure for the detection and semi-quantitation of human auto-antibodies.
IMP/IVD/2020/000420 · from United StatesAn indirect fluorescent antibody procedure for the detection and semi-quantitation of human auto-antibodies.
IMP/IVD/2020/000420 · from United StatesAn indirect fluorescent antibody procedure for the detection and semi-quantitation of human native nDNA auto-antibodies.
IMP/IVD/2020/000420 · from United StatesAn indirect fluorescent antibody procedure for the detection and semi-quantitation of human auto-antibodies.
IMP/IVD/2020/000420 · from United StatesAn indirect fluorescent antibody procedure for the detection and semi-quantitation of human native nDNA auto-antibodies.
IMP/IVD/2020/000420 · from United StatesThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5], EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5], EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated inoculum o…
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5]) to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh cult…
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5]) to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh cult…
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5], EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5], EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5]) to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh cult…
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5]) to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh cult…
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated inoculum o…
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain (CLSI [5], EUCAST [8], CA-SFM/EUCAST [9]) to the antimicrobial agent. The test is performed from a calibrated …
IMP/IVD/2018/000032 · from FranceThese disks are used as a semi-quantitative test to determine the in vitro clinical susceptibility category of a bacterial strain to the antimicrobial agent. The test is performed from a calibrated inoculum of pure and fresh culture of the …
IMP/IVD/2018/000032 · from FranceMueller-Hinton agar is a non-selective medium used for antimicrobial susceptibility testing, as standardized by the Clinical and Laboratory Standards Institute (CLSI) and the European Committee on Antimicrobial Susceptibility Testing (EUCAS…
IMP/IVD/2018/000032 · from FranceThe Kallestad® Anti-CCP II test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The assay is used to detect antibodie…
IMP/IVD/2020/000033 · from United StatesLiquichek Lipids Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: Apolipoprotein A-I, Apolipoprotein …
IMP/IVD/2023/000416 · from United StatesLiquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: ADNase B (Antideoxyribonuclease…
IMP/IVD/2023/000416 · from United StatesLiquichek Qualitative Urine Toxicology Control is intended for use as an assayed quality control urine to monitor the performance of laboratory procedures for qualitative urine toxicology. List of Analytes: 11-Nor-?-9-THC-9-COOH, 3,4-Methy…
IMP/IVD/2023/000416 · from United StatesLiquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: ADNase B (Antideoxyribonuclease…
IMP/IVD/2023/000416 · from United StatesLiquichek Sedimentation Rate Control is intended for use as a quality control to monitor the precision of erythrocyte sedimentation rate (ESR) laboratory testing procedures.
IMP/IVD/2023/000416 · from United StatesLiquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures. List of analytes: 11-Nor-delta-9-THC-9-COOH, Amphetamines, Barbiturate, Benzo…
IMP/IVD/2023/000416 · from United StatesLiquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. List of analytes: 11-Nor-?-9-THC-9-COOH, Alpha-Hydroxyalprazolam, Amobarbi…
IMP/IVD/2023/000416 · from United StatesLiquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology confirmatory procedures. List of analytes: 11-Nor-?-9-THC-9-COOH (1), Alpha-Hydroxyalprazolam, Amob…
IMP/IVD/2023/000416 · from United StatesLiquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures. List of Analytes: 11-Nor-delta-9-THC-9-COOH, Amphetamines, Barbiturate, Benzo…
IMP/IVD/2023/000416 · from United StatesLiquichek Urine Toxicology Control is intended for use as a quality control urine to monitor the performance of laboratory urine toxicology screening procedures. List of Analytes: 11-Nor-?-9-THC-9-COOH, Benzoylecgonine, d-Amphetamine, Etha…
IMP/IVD/2023/000416 · from United StatesLiquichek Therapeutic Drug Monitoring Control (TDM) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: Acetamin…
IMP/IVD/2023/000416 · from United StatesLiquichek Ethanol/Ammonia Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of Analytes: Ammonia, Ethanol
IMP/IVD/2023/000416 · from United StatesLiquichek Rheumatoid Factor Control is intended for use as an assayed quality control serum to monitor the precision of laboratory procedures for rheumatoid factor testing. List of analytes: Rheumatoid Factor.
IMP/IVD/2023/000416 · from United StatesLiquichek CK/LD Isoenzyme Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: Albumin, CK-MB Isoenzyme, …
IMP/IVD/2023/000416 · from United StatesLiquichek Spinal Fluid Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: Albumin, Chloride, Globuli…
IMP/IVD/2023/000416 · from United StatesLiquichek Unassayed Chemistry Control is intended for use as an unassayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. List of analytes: Acetaminophen, Acid …
IMP/IVD/2023/000416 · from United StatesMeter Trax Control is an assayed whole blood control used in monitoring the precision of laboratory procedures for glucose, hemoglobin and hematocrit testing. List of analytes: Glucose, Hematocrit, Hemoglobin.
IMP/IVD/2023/000416 · from United StatesGlobal footprint
Cross-railThe same manufacturer across regulators — 0 FDA clearances, 0 flagged adverse-event signals.
No FDA clearances linked — India-domestic footprint.
Sources: CDSCO (Central Drugs Standard Control Organisation) device licences · openFDA 510(k)/PMA · openFDA MAUDE · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert sign-off in progress.