Beckman Coulter India Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 71 |
| Class B | Low–moderate risk | 959 |
| Class C | Moderate–high risk | 227 |
| Class D (high risk) | Highest-risk devices | 17 |
CDSCO device licences
Erythrocyte Lytic Agent for quantitative determination of hemoglobin, enumeration of NRBC and counting and sizing leukocytes. Use only with DxH ECO Diluent or DxH concentrated ECO Diluent.
IMP/IVD/2018/000053 · from IrelandA non-fluorescent, azide free balanced electrolyte solution for use on COULTER Flow Cytometers with light scatter and fluorescent applications.
IMP/IVD/2025/000075 · from United StatesA nonionic, nonfluorescent, and azide-free sheath fluid for use on Beckman Coulter DxFLEX flow cytometers.
IMP/IVD/2025/000075 · from United StatesiQ Lamina is intended for in vitro diagnostic use with the iQ200 or DxU 840/850m Series of Automated Urine Microscopy Analyzers.
IMP/IVD/2026/000020 · from United StatesWas Solution is intended for use with IMMAGE Immunochemistry Systems and reagents for the quantitative determinations of components in biological fluids.
IMP/IVD/2025/000075 · from United StatesBeckman Coulter DxH Slides are specimen receptacles that are part of the UniCel DxH SMS II Coulter Cellular Analysis System, which includes a fully automated slide preparation and staining device that smears a blood film on a slide, and del…
IMP/IVD/2026/000007 · from United StatesMORE DIAGNOSTICS? Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product to check calibration in chemistry analyzers which measure rapamycin (sirolimus), tacrolimus and cyclosporine. This product is intended t…
IMP/IVD/2026/000003 · from United StatesMORE DIAGNOSTICS? Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product to check calibration in chemistry analyzers which measure rapamycin (sirolimus), tacrolimus and cyclosporine. This product is intended t…
IMP/IVD/2026/000003 · from United StatesMORE DIAGNOSTICS? Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product to check calibration in chemistry analyzers which measure rapamycin (sirolimus), tacrolimus and cyclosporine. This product is intended t…
IMP/IVD/2026/000003 · from United StatesiQ Body Fluids Controls are intended for use on iQ Series Analyzers, with the optional iQ Body Fluids Module installed, as a control for evaluating body fluid RBC and nucleated cell counts. The kit includes two levels of red blood cells and…
IMP/IVD/2019/000454 · from United StatesErythrocyte lytic agent for quantitative determination of Hemoglobin, and the counting, sizing and optical measurement of leukocytes on DxH 500 Series systems. Use only with DxH 500 Series Diluent and DxH 500 Series cleaner.
IMP/IVD/2025/000182 · from FranceA cleaning agent for use on UniCel DxH Coulter Cellular Analysis Systems for components that come in contact with blood samples.
IMP/IVD/2025/000075 · from United StatesA cleaning agent for use on UniCel DxH Coulter Cellular Analysis Systems for components that come in contact with blood samples.
IMP/IVD/2025/000075 · from United StatesFor use on UniCel DxH Coulter Cellular Analysis Systems to lyse erythrocytes and preserve leukocytes. Refer to your instrument product manuals and/or online help, as applicable.
IMP/IVD/2025/000075 · from United StatesFor use on UniCel DxH Coulter Cellular Analysis Systems for clearing red cells and staining reticulocytes.
IMP/IVD/2025/000075 · from United StatesThe Access Thyroglobulin Sample Diluent is intended for use with the Access Thyroglobulin assay to dilute patient samples containing thyroglobulin (Tg) concentrations greater than the S5 calibrator.
IMP/IVD/2019/000053 · from United StatesThe Emit Ethosuximide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of ethosuximide in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit II Plus Cannabinoid Assay is a homogeneous enzyme immunoassay with a 20 ng/mL, 50 ng/mL (SAMHSA initial test cutoff level), or 100 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of cann…
IMP/IVD/2020/000832 · from United StatesThe Emit 2000 Quinidine Calibrators are intended for use with the Emit 2000 Quinidine Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit tox Serum Tricyclic Antidepressants Calibrator/Controls are intended for use with the Emit tox Serum Tricyclic Antidepressants Assay for the qualitative analysis of specific tricyclic antidepressants in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit 2000 Tobramycin Calibrators are intended for use with the Emit 2000 Tobramycin Assay.
IMP/IVD/2020/000832 · from United StatesThe Emit Antiepileptic Drug Calibrators are intended for use with the Emit antiepileptic drug assays as a reference in measuring ethosuximide and primidone concentrations in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit Disopyramide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of disopyramide in human serum or plasma.
IMP/IVD/2020/000832 · from United StatesThe Emit tox Serum Tricyclic Antidepressants Assay is a homogeneous enzyme immunoassay intended for use in the qualitative analysis of specific tricyclic antidepressants in human serum or plasma. This assay is designed for use with most che…
IMP/IVD/2020/000832 · from United StatesThe Emit 2000 Tobramycin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of tobramycin in human serum or plasma. These reagents are packaged specifically for use on a variety of AU Clinical Chemistry …
IMP/IVD/2020/000832 · from United StatesPyridoxal Phosphate Liquid (Cat No. 60106) is supplied for Pyridoxal Phosphate Activation.
IMP/IVD/2019/000040 · from IrelandThe Emit 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. These reagents are packaged specifically for use on a variety of AU Clinical Chemistry S…
IMP/IVD/2020/000832 · from United StatesThe QMS Everolimus Control set is intended for use in quality control of the QMS Everolimus assay.
IMP/IVD/2020/000413 · from United StatesThe CEDIA Mycophenolic Acid (MPA) Calibrators are intended for use in the calibration of the CEDIA MPA Assay.
IMP/IVD/2020/000413 · from United StatesThe QMS Everolimus Calibrator set is intended for use in calibration of the QMS Everolimus assay.
IMP/IVD/2020/000413 · from United StatesThe QMS Everolimus assay is to be used for the quantitative determination of everolimus in human whole blood on automated clinical chemistry analyzers.
IMP/IVD/2020/000413 · from United StatesThe CEDIA® Mycophenolic Acid (MPA) Assay is an in vitro diagnostic medical device intended for the quantitative measurement of mycophenolic acid in human plasma using automated clinical chemistry analyzers as an aid in the management of myc…
IMP/IVD/2020/000413 · from United StatesMAS Mycophenolic Acid (MPA) Controls are intended for use as assayed quality control material for validation of MPA assays.
IMP/IVD/2020/000413 · from United StatesThe CEDIA Cyclosporine PLUS High Range calibrators are used to calibrate the CEDIA Cyclosporine PLUS High Range Assay in human whole blood. Each calibrator set is sold separately and may be used with any reagent lot.
IMP/IVD/2020/000413 · from United StatesMAS Mycophenolic Acid (MPA) Controls are intended for use as assayed quality control material for validation of MPA assays
IMP/IVD/2020/000413 · from United StatesMAS Mycophenolic Acid (MPA) Controls are intended for use as assayed quality control material for validation of MPA assays.
IMP/IVD/2020/000413 · from United StatesThe QMS Tacrolimus Calibrator set is intended for use in calibration of the QMS Tacrolimus Immunoassay
IMP/IVD/2020/000413 · from United StatesAccess Wash Buffer II is intended for use with the Access Immunoassay and specific Access immunoassay reagents.
IMP/IVD/2025/000075 · from United StatesThe UniCel DxI Access Immunoassay Systems Wash Buffer II Diluent pack is Intended for use with the UniCel DxI Immunoassay Systems
IMP/IVD/2025/000075 · 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® 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® 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® 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 Benzodiazepine Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of benzodiazepines in human urine. These reagen…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Methadone Assay is a homogeneous enzyme immunoassay with a 150 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of methadone in human urine. These reagents are packa…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Amphetamines Assay is a homogeneous enzyme immunoassay with a 300 ng/mL, 500 ng/mL (SAMHSA initial test cutoff level) or 1000 ng/mL cutoff.1 The assay is intended for use in the qualitative and semi-quantitative analyses o…
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Barbiturate Assay is a homogeneous enzyme immunoassay with a 200 ng/mL or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. These reagents are …
IMP/IVD/2020/000832 · from United StatesThe Emit® II Plus Opiate Assay is a homogeneous enzyme immunoassay with a 300 ng/mL or 2000 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of opiates in human urine. These reagents are packaged …
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® 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 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.