Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 0 |
| Class B | Low–moderate risk | 713 |
| Class C | Moderate–high risk | 207 |
| Class D (high risk) | Highest-risk devices | 12 |
CDSCO device licences
The Emit II LSD Assay is a homogeneous enzyme immunoassay with a 0.5 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of lysergic acid diethylamide (LSD) in human urine.
IMP/IVD/2020/000832 · from United StatesThe Emit Methotrexate Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of methotrexate in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.
IMP/IVD/2020/000832 · from United StatesThe Emit Amikacin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of amikacin in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit 2000 Procainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of procainamide in human serum or plasma. These reagents are packaged specifically for use on a variety of AU® Clinical Chemi…
IMP/IVD/2020/000832 · from United StatesThe Emit LSD Calibrators are for use only with the Emit II LSD Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.
IMP/IVD/2020/000832 · from United StatesThe Emit LSD Controls are intended for use in verifying the correct functioning and to confirm calibration of the Emit® II LSD Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit® Primidone Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of primidone in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit 2000 Procainamide Calibrators are intended for use with the Emit 2000 Procainamide Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.
IMP/IVD/2020/000832 · from United StatesThe Emit Lidocaine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of lidocaine in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit® Caffeine Control is intended for use in validating instrument and Emit® Caffeine Assay performance.
IMP/IVD/2020/000832 · from United StatesThe Emit LSD Calibrators are for use only with the Emit® II LSD Assay
IMP/IVD/2020/000832 · from United StatesThe Emit LSD Controls are intended for use in verifying the correct functioning and to confirm calibration of the Emit® II LSD Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit® Calibrators/Controls are used in the calibration of the Emit® II Plus Amphetamines, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Ecstasy, Methadone, Methaqualone, Monoclonal Amphetamine/Methamphetamine, Opiates, P…
IMP/IVD/2020/000832 · from United StatesThe Emit LSD Calibrators are for use only with the Emit® II LSD Assay
IMP/IVD/2020/000832 · from United StatesThe Emit LSD Calibrators are for use only with the Emit® II LSD Assay
IMP/IVD/2020/000832 · from United StatesThe Emit® Calibrators/Controls are used in the calibration of the Emit® II Plus Amphetamines, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Ecstasy, Methadone, Methaqualone, Monoclonal Amphetamine/Methamphetamine, Opiates, P…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.
IMP/IVD/2020/000832 · from United StatesThe Emit® Calibrators/Controls are used in the calibration of the Emit® II Plus Amphetamines, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Ecstasy, Methadone, Methaqualone, Monoclonal Amphetamine/Methamphetamine, Opiates, P…
IMP/IVD/2020/000832 · from United StatesThe Emit II Plus Phencyclidine Assay is a homogeneous enzyme immunoassay with a 25 ng/mL cutoff (SAMHSA initial test cutoff level). The assay is intended for use in the qualitative and semiquantitative analyses of phencyclidine in human uri…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Specialty Drug Calibrators/Controls are used in the calibration of the Emit® II Plus Buprenorphine Assay. These products may also be used as quality control materials based on the Buprenorphine Assay cutoff.
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Buprenorphine Assay is a homogeneous enzyme immunoassay with a 5 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of buprenorphine in human urine. Emit® II Pl…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Ecstasy Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 500 ng/mL cutoff. The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of methylenedioxymethamphetamine (M…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Specialty Drug Control Negative and Control Positive are for use with the Emit® II Plus Buprenorphine Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit® Calibrators/Controls are used in the calibration of the Emit® II Plus Amphetamines, Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Ecstasy, Methadone, Methaqualone, Monoclonal Amphetamine/Methamphetamine, Opiates, P…
IMP/IVD/2020/000832 · from United StatesThe Emit® Caffeine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of caffeine levels in human serum in subjects undergoing therapy with caffeine, especially in cases of neonatal apnea.
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus 6-Acetylmorphine Assay is a homogeneous enzyme immunoassay with a 10 ng/mL cutoff.1 The assay is intended for use in laboratories for the qualitative and/or semiquantitative analyses of 6-acetylmorphine (6-AM), a heroin me…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Ethyl Alcohol Assay is intended for use in the quantitative analysis of ethyl alcohol (ethanol) in human urine, serum, or plasma. These reagents are packaged specifically for use on a variety of AU® Clinical Chemistry Syst…
IMP/IVD/2020/000832 · from United StatesThe Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays.
IMP/IVD/2020/000832 · from United StatesThe Emit II Plus Methaqualone Assay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methaqualone in human urine. These reagents are packaged spec…
IMP/IVD/2020/000832 · from United StatesThe Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays.
IMP/IVD/2020/000832 · from United StatesThe Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays
IMP/IVD/2020/000832 · from United StatesThe Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays.
IMP/IVD/2020/000832 · from United StatesThe Access Toxo IgG Calibrators are intended to calibrate the Access Toxo IgG assay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from FranceThe Access Rubella IgM QC is intended for monitoring system performance of the Access Rubella IgM assay.
IMP/IVD/2019/000208 · from FranceThe Access Toxo IgG assay is a paramagnetic-particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to Toxoplasma gondii in human serum using the Access Immunoassay Systems. The Access Tox…
IMP/IVD/2019/000208 · from FranceThe Access Rubella IgM Calibrators are intended for use with the Access Rubella IgM assay for the detection of anti-Rubella virus IgM in human serum using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from FranceThe Access Rubella IgG QC is intended for monitoring system performance of the Access Rubella IgG assay.
IMP/IVD/2019/000208 · from FranceThe Access Rubella IgM assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of anti-Rubella virus IgM in human serum using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from United StatesThe Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay
IMP/IVD/2019/000208 · from FranceThe Access HAV IgM QC is intended for monitoring system performance of the Access HAV IgM assay.
IMP/IVD/2019/000208 · from United StatesThe Access HAV IgM assay is a paramagnetic-particle, chemiluminescent immunoassay for the detection of IgM antibody to hepatitis A virus in human serum and plasma using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from FranceThe Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from FranceThe Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. The Access …
IMP/IVD/2019/000208 · from FranceThe Access HAV IgM Calibrators are intended for use with the Access HAV IgM assay for the detection of IgM antibody to hepatitis A virus antigen in human serum and plasma using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from United StatesThe Access Toxo IgM II Calibrators are intended for use with the Access Toxo IgM II assay for the qualitative detection of Toxoplasma gondii-specific IgM antibody in adult human serum and plasma using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from FranceThe Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems.
IMP/IVD/2019/000208 · from United StatesThe Access CEA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. CEA measured by the Access Immun…
IMP/IVD/2019/000208 · from FranceGlobal 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.