Abbott Healthcare Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 62 |
| Class B | Low–moderate risk | 1,262 |
| Class C | Moderate–high risk | 734 |
| Class D (high risk) | Highest-risk devices | 260 |
CDSCO device licences
The MULTIGENT Cannabinoids assay is intended for the qualitative and semiquantitative determination of cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of total L-homocysteine in human serum or plasma.
IMP/IVD/2021/000030 · from United KingdomThe ARCHITECT 2nd Generation Testosterone Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of testosterone in human serum and plasma.
IMP/IVD/2021/000030 · from GermanyThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe ARCHITECT 2nd Generation Testosterone assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma. Measurements of testosterone are used in the diagnosis and …
IMP/IVD/2021/000030 · from United KingdomThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe MULTIGENT Cannabinoids Calibrators and Controls are intended for the calibration and quality control of the MULTIGENT Cannabinoids assay, which detects cannabinoids (THC) in human urine on the ARCHITECT c Systems.
IMP/IVD/2019/000385 · from United StatesThe ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument), when used for the quantitative determination…
IMP/IVD/2021/000030 · from GermanyThe ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT iSystem. Homocysteine values can assist in the diag…
IMP/IVD/2021/000030 · from GermanyThe ARCHITECT 2nd Generation Testosterone Controls are for the verification of the accuracy and precision of the ARCHITECT iSystem when used for the quantitative determination of testosterone in human serum and plasma.
IMP/IVD/2021/000030 · from GermanyThe ARCHITECT Anti-CCP assay is a chemiluminescent microparticle immunoassay (CMIA) for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma on the AR…
IMP/IVD/2021/000030 · from United KingdomThe ARCHITECT Anti-CCP Calibrators are for the calibration of the ARCHITECT iSystem when used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma…
IMP/IVD/2021/000030 · from United KingdomThe Alinity i Anti-CCP assay is a chemiluminescent microparticle immunoassay (CMIA) used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma on t…
IMP/IVD/2021/000030 · from GermanyThe Alinity i Anti-CCP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i analyzer (reagents, calibrators and instrument) when used for the semi-quantitative determinatio…
IMP/IVD/2021/000030 · from United KingdomThe Alinity i Anti-CCP Calibrators are for the calibration of the Alinity i analyzer when used for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasm…
IMP/IVD/2021/000030 · from United KingdomThe ARCHITECT Anti-CCP Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem (reagents, calibrators and instrument) when used for the semi-quantitative determination…
IMP/IVD/2021/000030 · from GermanyThe Alinity c DOA MC I Controls are used for the quality control of drug of abuse (DOA) assays for amphetamine/methamphetamine, barbiturates, benzodiazepines, cocaine metabolites, methadone, opiates, phencyclidine, and propoxyphene in human…
IMP/IVD/2019/000385 · from United StatesThe Alinity c DOA MC Semiquant Calibrators are used for the calibration of drug of abuse (DOA) assays for amphetamine/ methamphetamine, barbiturates, cocaine metabolites, methadone, opiates, phencyclidine, and propoxyphene in human urine on…
IMP/IVD/2019/000385 · from United StatesThe Alinity c Methadone assay is used for the qualitative and semiquantitative determination of methadone in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c DOA MC Negative Calibrator is used for the calibration of drug of abuse (DOA) assays for amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, ecstasy, methadone, opiates, phencyclidine…
IMP/IVD/2019/000385 · from United StatesThe Alinity c DOA MC Qual Low Calibrator 1 is used for the calibration of drug of abuse (DOA) assays for amphetamine/ methamphetamine and cocaine metabolites in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c DOA MC Qual Calibrator 2 is used for the calibration of drug of abuse (DOA) assays for amphetamine/methamphetamine, barbiturates, cocaine metabolites, methadone, opiates, phencyclidine, and propoxyphene in human urine on the A…
IMP/IVD/2019/000385 · from United StatesThe Alinity c Barbiturates assay is used for the qualitative and semiquantitative determination of barbiturates in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Phencyclidine assay is used for the qualitative and semiquantitative determination of phencyclidine in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Amphetamine/Methamphetamine assay is used for the qualitative and semiquantitative determination of amphetamine/methamphetamine in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c DOA MC III Controls are used for the quality control of drug of abuse (DOA) assays for amphetamine/methamphetamine and opiates in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Propoxyphene assay is used for the qualitative and semiquantitative determination of propoxyphene in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c DOA MC II Controls are used for the quality control of drug of abuse (DOA) assays for cocaine metabolites and ecstasy in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cannabinoids Control 1 controls are intended for the quality control of the Alinity c Cannabinoids assay, which detects cannabinoids (THC) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cannabinoids Control 2 controls are intended for the quality control of the Alinity c Cannabinoids assay, which detects cannabinoids (THC) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Opiates Semiquant Calibrators are intended for the calibration of the Alinity c Opiates assay, which detects opiates in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Opiates assay is used for the qualitative and semiquantitative determination of opiates in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesFor in vitro diagnostic use in the calibration of the Alinity c Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Theophylline, Valproic Acid, and Vancomycin human serum or plasma assays on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Ecstasy Qual Calibrator is intended for the calibration of the Alinity c Ecstasy assay, which detects 3,4-methylenedioxymethamphetamine (MDMA) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cocaine assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 …
IMP/IVD/2019/000385 · from United StatesThe Alinity c Ecstasy assay is used for the qualitative and semiquantitative determination of ecstasy in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Ecstasy Semiquant Calibrators are intended for the calibration of the Alinity c Ecstasy assay, which detects 3,4-methylenedioxymethamphetamine (MDMA) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Tricyclic Antidepressants assay is used for the qualitative and semiquantitative determination of tricyclic antidepressants in human serum or plasma using 300 ng/mL as a cutoff calibrator on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Opiates Qual Calibrator is intended for the calibration of the Alinity c Opiates assay, which detects opiates in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cannabinoids Semiquant 100 Calibrators are intended for the calibration of the Alinity c Cannabinoids assay, which detects cannabinoids (THC) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cannabinoids assay is used for the qualitative and semiquantitative determination of cannabinoids (THC) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cannabinoids Semiquant 200 Calibrators are intended for the calibration of the Alinity c Cannabinoids assay, which detects cannabinoids (THC) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Cannabinoids Qual Calibrator is intended for the calibration of the Alinity c Cannabinoids assay, which detects cannabinoids (THC) in human urine on the Alinity c analyzer.
IMP/IVD/2019/000385 · from United StatesThe Alinity c Gentamicin assay is used for the quantitative determination of gentamicin in human serum or plasma on the Alinity c analyzer. The results obtained are used in the diagnosis and treatment of gentamicin overdose and in monitorin…
IMP/IVD/2019/000385 · from United StatesThe Alinity c Carbamazepine assay is used for the in vitro quantitative measurement of carbamazepine in human serum or plasma on the Alinity c analyzer.
IMP/IVD/2019/000385 · 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.