Importer / authorised agent · Tamil Nadu · India

Beckman Coulter India Private Limited Hisaria Warehouse Ground Floor

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
932
Manufacturing
0
Import
932
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices0
Class BLow–moderate risk713
Class CModerate–high risk207
Class D (high risk)Highest-risk devices12

CDSCO device licences

Emit II LSD Assay · Class CIMPORT · 2025-08-05

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 States
Emit Methotrexate Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Specialty Drug Calibrator/ Control Level 4 · Class CIMPORT · 2025-08-05

The 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 States
Emit Amikacin Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit 2000 Procainamide Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit LSD 0 ng/mL Calibrator · Class CIMPORT · 2025-08-05

The Emit LSD Calibrators are for use only with the Emit II LSD Assay.

IMP/IVD/2020/000832 · from United States
Emit II Plus Specialty Drug Calibrator/ Control Level 3 · Class CIMPORT · 2025-08-05

The 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 States
Emit LSD Control Level 1 · Class CIMPORT · 2025-08-05

The 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 States
Emit Primidone Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit 2000 Procainamide Calibrators · Class CIMPORT · 2025-08-05

The Emit 2000 Procainamide Calibrators are intended for use with the Emit 2000 Procainamide Assay.

IMP/IVD/2020/000832 · from United States
Emit II Plus Specialty Drug Calibrator/ Control Level 1 · Class CIMPORT · 2025-08-05

The 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 States
Emit Lidocaine Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit Caffeine Control · Class CIMPORT · 2025-08-05

The Emit® Caffeine Control is intended for use in validating instrument and Emit® Caffeine Assay performance.

IMP/IVD/2020/000832 · from United States
Emit LSD 1.5 ng/mL Calibrator · Class CIMPORT · 2025-08-05

The Emit LSD Calibrators are for use only with the Emit® II LSD Assay

IMP/IVD/2020/000832 · from United States
Emit LSD Control Level 2 · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 3 · Class CIMPORT · 2025-08-05

The 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 States
Emit LSD 0.5 ng/mL Calibrator · Class CIMPORT · 2025-08-05

The Emit LSD Calibrators are for use only with the Emit® II LSD Assay

IMP/IVD/2020/000832 · from United States
Emit LSD 2.5 ng/mL Calibrator · Class CIMPORT · 2025-08-05

The Emit LSD Calibrators are for use only with the Emit® II LSD Assay

IMP/IVD/2020/000832 · from United States
Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 2 · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Specialty Drug Control Negative · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 4 · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Phencyclidine Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Specialty Drug Calibrator/ Control Level 2 · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Buprenorphine Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Ecstasy Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Specialty Drug Control Positive · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus 6-AM/ Ecstasy Calibrator/ Control Level 1 · Class CIMPORT · 2025-08-05

The 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 States
Emit Caffeine Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus 6-Acetylmorphine Assay · Class CIMPORT · 2025-08-05

The 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 States
Emit II Plus Ethyl Alcohol Assay · Class CIMPORT · 2025-07-22

The 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 States
Emit Ethyl Alcohol Negative Calibrator · Class CIMPORT · 2025-07-22

The Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays.

IMP/IVD/2020/000832 · from United States
Emit II Plus Methaqualone Assay · Class CIMPORT · 2025-07-22

The 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 States
Emit Ethyl Alcohol High Control · Class CIMPORT · 2025-07-22

The Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays.

IMP/IVD/2020/000832 · from United States
Emit Ethyl Alcohol Low Control · Class CIMPORT · 2025-07-22

The Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays

IMP/IVD/2020/000832 · from United States
Emit Ethyl Alcohol 100 mg/dL Calibrator · Class CIMPORT · 2025-07-22

The Emit® Ethyl Alcohol Calibrators and Controls are for use with the Emit® Ethyl Alcohol Assays.

IMP/IVD/2020/000832 · from United States
Access Toxo IgG Calibrators · Class CIMPORT · 2025-07-02

The 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 France
Access Rubella IgM QC · Class CIMPORT · 2025-07-02

The Access Rubella IgM QC is intended for monitoring system performance of the Access Rubella IgM assay.

IMP/IVD/2019/000208 · from France
Access Toxo IgG · Class CIMPORT · 2025-07-02

The 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 France
Access Rubella IgM Calibrators · Class CIMPORT · 2025-07-02

The 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 France
Access Rubella IgG QC · Class CIMPORT · 2025-07-02

The Access Rubella IgG QC is intended for monitoring system performance of the Access Rubella IgG assay.

IMP/IVD/2019/000208 · from France
Access Rubella IgM · Class CIMPORT · 2025-07-02

The 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 States
Access Toxo IgG QC · Class CIMPORT · 2025-07-02

The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay

IMP/IVD/2019/000208 · from France
Access HAV IgM QC · Class CIMPORT · 2025-07-02

The Access HAV IgM QC is intended for monitoring system performance of the Access HAV IgM assay.

IMP/IVD/2019/000208 · from United States
Access HAV IgM · Class CIMPORT · 2025-07-02

The 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 France
Access Rubella IgG Calibrators · Class CIMPORT · 2025-07-02

The 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 France
Access Rubella IgG · Class CIMPORT · 2025-07-02

The 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 France
Access HAV IgM Calibrators · Class CIMPORT · 2025-07-02

The 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 States
Access Toxo IgM II Calibrators · Class CIMPORT · 2025-07-02

The 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 France
Access CEA Calibrators · Class CIMPORT · 2025-07-02

The 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 States
Access CEA · Class CIMPORT · 2025-07-02

The 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 France

Global footprint

Cross-rail

The 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.

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