Importer / authorised agent · Tamil Nadu · India

Beckman Coulter India Private Limited

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
1,274
Manufacturing
7
Import
1,267
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices71
Class BLow–moderate risk959
Class CModerate–high risk227
Class D (high risk)Highest-risk devices17

CDSCO device licences

ECO Cell Lyse · Class BIMPORT · 2026-05-08

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 Ireland
IsoFlow Sheath Fluid · Class BIMPORT · 2026-03-20

A 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 States
DxFLEX Sheath Fluid · Class BIMPORT · 2026-03-20

A nonionic, nonfluorescent, and azide-free sheath fluid for use on Beckman Coulter DxFLEX flow cytometers.

IMP/IVD/2025/000075 · from United States
iQ Lamina · Class BIMPORT · 2026-02-06

iQ 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 States
Immnochemistry Systems Wash Solution · Class BIMPORT · 2026-01-19

Was 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 States
Beckman Coulter DxH Slides · Class AIMPORT · 2026-01-15

Beckman 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 States
Rap/Tac/CsA Control ? Level 1 · Class CIMPORT · 2026-01-06

MORE 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 States
Rap/Tac/CsA Control ? Level 3 · Class CIMPORT · 2026-01-06

MORE 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 States
Rap/Tac/CsA Control ? Level 2 · Class CIMPORT · 2026-01-06

MORE 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 States
iQ Body Fluids Controls - Level I and Level II · Class BIMPORT · 2025-12-18

iQ 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 States
DxH 500 Series Lyse · Class BIMPORT · 2025-12-15

Erythrocyte 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 France
COULTER DxH CLEANER 5L · Class BIMPORT · 2025-11-14

A 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 States
COULTER DxH CLEANER 10L · Class BIMPORT · 2025-11-14

A 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 States
COULTER DxH Diff Pack · Class BIMPORT · 2025-09-29

For 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 States
COULTER DxH Retic Pack · Class BIMPORT · 2025-09-29

For use on UniCel DxH Coulter Cellular Analysis Systems for clearing red cells and staining reticulocytes.

IMP/IVD/2025/000075 · from United States
Access Thyroglobulin Sample Diluent · Class BIMPORT · 2025-08-21

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

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

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

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

IMP/IVD/2020/000832 · from United States
Emit tox Serum Tricyclic Antidepressants Calibrator/Controls · Class CIMPORT · 2025-08-05

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

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

IMP/IVD/2020/000832 · from United States
Emit Antiepileptic Drug Calibrators · Class CIMPORT · 2025-08-05

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

The 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 States
Emit tox Serum Tricyclic Antidepressants Assay · Class CIMPORT · 2025-08-05

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

The 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 States
Pyridoxal Phosphate Liquid · Class BIMPORT · 2025-08-05

Pyridoxal Phosphate Liquid (Cat No. 60106) is supplied for Pyridoxal Phosphate Activation.

IMP/IVD/2019/000040 · from Ireland
Emit 2000 Quinidine Assay · Class CIMPORT · 2025-08-05

The 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 States
QMS Everolimus Immunoassay Control · Class CIMPORT · 2025-08-01

The QMS Everolimus Control set is intended for use in quality control of the QMS Everolimus assay.

IMP/IVD/2020/000413 · from United States
CEDIA Mycophenolic Acid Calibrators · Class CIMPORT · 2025-08-01

The CEDIA Mycophenolic Acid (MPA) Calibrators are intended for use in the calibration of the CEDIA MPA Assay.

IMP/IVD/2020/000413 · from United States
QMS Everolimus Immunoassay Calibrator · Class CIMPORT · 2025-08-01

The QMS Everolimus Calibrator set is intended for use in calibration of the QMS Everolimus assay.

IMP/IVD/2020/000413 · from United States
QMS Everolimus Immunoassay Reagent · Class CIMPORT · 2025-08-01

The 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 States
CEDIA Mycophenolic Acid Assay · Class CIMPORT · 2025-08-01

The 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 States
MAS Liquid Mycophenolic Acid Control Level 1 · Class CIMPORT · 2025-08-01

MAS Mycophenolic Acid (MPA) Controls are intended for use as assayed quality control material for validation of MPA assays.

IMP/IVD/2020/000413 · from United States
CEDIA Cyclosporine PLUS High Range Calibrators · Class CIMPORT · 2025-08-01

The 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 States
MAS Liquid Mycophenolic Acid Control Level 2 · Class CIMPORT · 2025-08-01

MAS Mycophenolic Acid (MPA) Controls are intended for use as assayed quality control material for validation of MPA assays

IMP/IVD/2020/000413 · from United States
MAS Liquid Mycophenolic Acid Control Level 3 · Class CIMPORT · 2025-08-01

MAS Mycophenolic Acid (MPA) Controls are intended for use as assayed quality control material for validation of MPA assays.

IMP/IVD/2020/000413 · from United States
QMS Tacrolimus Immunoassay Calibrator · Class CIMPORT · 2025-08-01

The QMS Tacrolimus Calibrator set is intended for use in calibration of the QMS Tacrolimus Immunoassay

IMP/IVD/2020/000413 · from United States
Access Wash Buffer II · Class BIMPORT · 2025-07-14

Access Wash Buffer II is intended for use with the Access Immunoassay and specific Access immunoassay reagents.

IMP/IVD/2025/000075 · from United States
Unicel DxI Access Wash Buffer II · Class BIMPORT · 2025-07-14

The 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 States
Emit Calibrator/Control Level 1 · Class CIMPORT · 2025-07-10

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 Calibrator/Control Level 5 · Class CIMPORT · 2025-07-10

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 Calibrator/Control Level 4 · Class CIMPORT · 2025-07-10

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 Calibrator/Control Level 2 · Class CIMPORT · 2025-07-10

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 Benzodiazepine Assay · Class CIMPORT · 2025-07-10

The 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 States
Emit II Plus Methadone Assay · Class CIMPORT · 2025-07-10

The 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 States
Emit II Plus Amphetamines Assay · Class CIMPORT · 2025-07-10

The 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 States
Emit II Plus Barbiturate Assay · Class CIMPORT · 2025-07-10

The 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 States
Emit II Plus Opiate Assay · Class CIMPORT · 2025-07-10

The 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 States
Emit Calibrator/Control Level 0 · Class CIMPORT · 2025-07-10

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 Calibrator/Control Level 3 · Class CIMPORT · 2025-07-10

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

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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