Importer / authorised agent · Delhi · India

INSTRUMENTATION LABORATORY INDIA PVT. LTD.

CDSCO licensing intelligence, reconciled with the manufacturer’s global footprint · AI-reviewed · expert verification in progress — not yet independently verified.
CDSCO licences
622
Manufacturing
0
Import
622
FDA clearances
321

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices35
Class BLow–moderate risk320
Class CModerate–high risk201
Class D (high risk)Highest-risk devices66

CDSCO device licences

Analyzer · Class CIMPORT · 2026-05-04

The Neo Iris (NEO Iris) is a microprocessor-controlled instrument to fully automate immunohematology in vitro diagnostic testing of human blood. The NEO Iris automates test processing, result interpretation and data management functions. Th…

IMP/IVD/2026/000074 · from Germany
HemosIL D-Dimer · Class CIMPORT · 2026-05-04

Automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromb…

IMP/IVD/2026/000073 · from United States
HemosIL Acustar D-Dimer · Class CIMPORT · 2026-05-04

HemosIL Acustar D-Dimer is a fully automated chemiluminescent immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL Acustar/BIO-FLASH in the laboratory seeting as an aid in the diagnosis of venous thr…

IMP/IVD/2026/000073 · from Spain
HemosIL Acustar D-Dimer Controls · Class CIMPORT · 2026-05-04

HemosIL AcuStar D-Dimer Controls are for the quality control of the HemosIL AcuStar D-Dimer assay on the ACL AcuStar®/BIO-FLASH® in the laboratory setting.

IMP/IVD/2026/000073 · from Spain
HemosIL D-Dimer HS · Class CIMPORT · 2026-05-04

HemosIL D-Dimer HS is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family?, ACL TOP Family 50 Series??, and ACL TOP Family 70 Series???, for use in conjunctio…

IMP/IVD/2026/000073 · from Spain
HemosIL D-Dimer HS 500 Controls · Class CIMPORT · 2026-05-04

HemosIL D-Dimer HS 500 Controls are for the quality control of the HemosIL D-Dimer HS 500 assay on the ACL TOP® Family?, ACL TOP Family 50 Series??, and ACL TOP Family 70 Series??? in the laboratory setting.

IMP/IVD/2026/000073 · from Spain
HemosIL D-Dimer HS 500 · Class CIMPORT · 2026-05-04

HemosIL D-Dimer HS 500 is an automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on the ACL TOP® Family?, ACL TOP Family 50 Series??, and ACL TOP Family 70 Series??? for use in conjunc…

IMP/IVD/2026/000073 · from United States
HemosIL D-Dimer 500 · Class CIMPORT · 2026-05-04

HemosIL D-Dimer 500 is an automated latex enhanced immunoassay for the quantitative determination of D- Dimer in human citrated plasma on ACL TOP Family, ACL TOP Famiy 50 Series, ACL TOP Family 70 series, and ACL Elite/Elite Pro,for use in…

IMP/IVD/2026/000073 · from Spain
HemosIL D-Dimer Controls · Class CIMPORT · 2026-05-04

HemosIL D-Dimer Controls are for the quality control of the HemosIL D-Dimer, HemosIL D-Dimer 500, and HemosIL D-Dimer HS assays on the ACL TOP® Family?, ACL TOP Family 50 Series??, and ACL TOP Family 70 Series??? and for the quality control…

IMP/IVD/2026/000073 · from United States
IL Performance Verification Product · Class CIMPORT · 2026-04-27

IL Performance Verification Product (PVP) is used for testing system performance of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, tBili and total hemoglobin across the analytical reportable range on GEM® Premier? analyzers.

IMP/IVD/2025/000067 · from United States
HemosIL Liquid Antithrombin · Class CIMPORT · 2026-04-01

Automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma on the IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Liquid Antithrombin · Class CIMPORT · 2026-04-01

Automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma on the ACL TOP® Systems.

IMP/IVD/2020/000615 · from United States
HemosIL RecombiPlasTin 2G (20 mL) · Class CIMPORT · 2026-04-01

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for …

IMP/IVD/2020/000615 · from United States
HemosIL QFA Thrombin (Bovine) · Class CIMPORT · 2026-04-01

For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on the IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Factor VIII Deficient Plasma · Class CIMPORT · 2026-04-01

HemosIL Factor VIII deficient plasma is human plasma, depleted of Factor VIII, which is intended for the in vitro diagnostic quantitative determination of Factor VIII activity in citrated plasma, based on the activated partial thromboplasti…

IMP/IVD/2020/000615 · from United States
HemosIL AcuStar ADAMTS13 Activity · Class CIMPORT · 2026-03-13

The HemosIL AcuStar ADAMTS13 Activity is a quantitative, fully automated, chemiluminescent immunoassay (CIA) for the measurement of ADAMTS13 Activity. The assay is for use in human 3.2% or 3.8% citrated plasma on the ACL AcuStar ® in a lab…

IMP/IVD/2020/000337 · from United States
HemosIL Factor X Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor X for the quantitative determination of factor X activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Factor VIII Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor VIII for the quantitative determination of factor VIII (FVIII) activity in citrated plasma, based on activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL SynthAFax · Class CIMPORT · 2026-02-24

A high quality synthetic phospholipids reagent for the in vitro determination of Activated Partial Thromboplastin Time(APTT) in human citrated plasma on IL Coagulation Systems. The product is used for the evaluation of the intrinsic coagula…

IMP/IVD/2020/000615 · from United States
HemosIL Factor V Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor V for the quantitative determination of factor V activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Protein S Activity · Class CIMPORT · 2026-02-24

Automated coagulation functional assay for the quantitative determination of free Protein S in human citrated plasma on the ACL TOP® Family, ACL TOP Family 50 Series, ACL Elite®/Elite Pro and ACL 7000 Systems as an aid in the diagnosis of h…

IMP/IVD/2020/000615 · from United States
HemosIL RecombiPlasTin 2G (5 x 8 mL) · Class CIMPORT · 2026-02-24

A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for …

IMP/IVD/2020/000615 · from United States
HemosIL Silica Clotting Time · Class CIMPORT · 2026-02-24

For the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

IMP/IVD/2020/000615 · from United States
HemosIL ReadiPlasTin (20mL) · Class CIMPORT · 2026-02-24

HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family an…

IMP/IVD/2020/000615 · from United States
HemosIL dRVVT Screen · Class CIMPORT · 2026-02-24

The dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulantsin human citrated plasma by the diluted Russell?s Viper Venom method, on IL Coagulation Systems. T…

IMP/IVD/2020/000615 · from United States
HemosIL Thrombin Time · Class CIMPORT · 2026-02-24

For the quantitative determination of Thrombin Time (TT) in human citrated plasma on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
Electrachrome Factor VIII · Class CIMPORT · 2026-02-24

For the photometric determination of factor VIII activity in human citrated plasma. This includes detection of factor VIII deficiency, monitoring patients on replacement therapy and for potency estimation offactor VIII concentrates.

IMP/IVD/2020/000615 · from United States
HemosIL Direct Thrombin Inhibitor Assay · Class CIMPORT · 2026-02-24

The HemosIL Direct Thrombin Inhibitor (DTI) Assay is an in vitro diagnostic assay for the quantitative determination of the Direct Thrombin Inhibitor Dabigatran in citrated human plasma on the ACL TOP Family of analyzers. The product is int…

IMP/IVD/2020/000615 · from United States
HemosIL Factor V Leiden (APC Resistance V) · Class CIMPORT · 2026-02-24

For determination of resistance to activated Protein C, caused by the Factor V:Q 506 (Factor V Leiden) mutation, in plasma from untreated individuals and from patients on oral anti-coagulant(OAT) or heparin therapy.

IMP/IVD/2020/000615 · from United States
HemosIL APTT-SP · Class CIMPORT · 2026-02-24

For the in vitro determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients rec…

IMP/IVD/2020/000615 · from United States
HemosIL Plasmin Inhibitor · Class CIMPORT · 2026-02-24

Automated chromogenic assay for the quantitative determination of Plasmin Inhibitor in human citrated plasma on IL Coagulation Systems

IMP/IVD/2020/000615 · from United States
HemosIL Factor IX Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor IX for the quantitative determination of factor IX activity in citrated plasma, based on activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Plasminogen · Class CIMPORT · 2026-02-24

Automated chromogenic assay for the quantitative determination of Plasminogen in human citrated plasma on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Heparin · Class CIMPORT · 2026-02-24

Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on the IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Factor XII Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor XII for the quantitative determination of factor XII (FXII) activity in citrated plasma, based on activated partial thromboplastin time (APTT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Liquid Antithrombin · Class CIMPORT · 2026-02-24

Automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma on the IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Proclot · Class CIMPORT · 2026-02-24

Automated functional clotting Protein C assay for the quantitative determination of Protein C in human citrated plasma on the IL Coagulation Systems

IMP/IVD/2020/000615 · from United States
HemosIL SynthASil · Class CIMPORT · 2026-02-24

A high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation Systems. The product is used for the evaluation of the intrinsic coagul…

IMP/IVD/2020/000615 · from United States
HemosIL PT-Fibrinogen HS PLUS · Class CIMPORT · 2026-02-24

A very high sensitivity calcium thromboplastin for simultaneous determinations of Prothrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsic coagulation pathway and monitoring Oral Anticoagulant Therapy inhuman citrated pla…

IMP/IVD/2020/000615 · from United States
HemosIL Fibrinogen-C (10x2ml) · Class CIMPORT · 2026-02-24

For the quantitative determination of fibrinogen, based on the Clauss method, in human citrated plasma on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Protein C · Class CIMPORT · 2026-02-24

Automated chromogenic assay for the quantitative determination of Protein C in human citrated plasma on ILCoagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Factor XI Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor XI for the quantitative determination of factor XI activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL coagulation systems.

IMP/IVD/2020/000615 · from United States
HemosIL Factor VII Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of factor VII for the quantitative determination of factor VII activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
HemosIL Liquid Anti-Xa · Class CIMPORT · 2026-02-24

Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACL TOP® Family, ACL TOP Family 50 Series a…

IMP/IVD/2020/000615 · from United States
HemosIL Factor II Deficient Plasma · Class CIMPORT · 2026-02-24

Human plasma immunodepleted of Factor II for the quantitative determination of Factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation Systems.

IMP/IVD/2020/000615 · from United States
Anti-K (Monoclonal) Gamma-clone · Class DIMPORT · 2026-02-17

Gamma-clone Anti-K (Monoclonal) is intended for the detection of the K (Kell KEL 1) antigen on red blood cells by tube test

IMP/IVD/2025/000060 · from United States
QUANTA Lite® HMGCR ELISA · Class BIMPORT · 2026-02-12

The QUANTA Lite HMGCR ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of anti-HMGCR (3-Hydroxy-3-Methylglutaryl Coenzyme A Reductase) antibodies (IgG) in patient sera. The presence of these antibodies, when c…

IMP/IVD/2019/000323 · from United States
QUANTA Lite® h-tTG Screen ELISA · Class BIMPORT · 2026-02-12

QUANTA Lite h-tTG Screen is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgA and IgG antibodies to human tissue transglutaminase (h-tTG) in human serum. The presence of these antibodies can be used in …

IMP/IVD/2019/000323 · from United States
QUANTA Lite® Phosphatidylserine IgA ELISA · Class BIMPORT · 2026-02-12

This assay is intended for the in-vitro measurement of IgA anti-phosphatidylserine antibodies in human serum, as an aid in the diagnosis of anti-phospholipid syndrome (APS). Sufficient materials are supplied to allow a maximum of 41 samples…

IMP/IVD/2019/000323 · from United States
QUANTA Flash® Ribosomal P Reagents · Class BIMPORT · 2026-02-12

The QUANTA Flash Ribosomal P is a chemiluminescent immunoassay (CIA) for the semi-quantitative determination of IgG anti-ribosomal P antibodies in human serum. The presence of anti-ribosomal P antibodies, in conjunction with clinical findin…

IMP/IVD/2019/000323 · from United States

Global footprint

Cross-rail

The same manufacturer across regulators — 321 FDA clearances, 0 flagged adverse-event signals.

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM · JPAFDA · 2023-09-29
HemosIL Liquid Anti-Xa · QLUFDA · 2023-06-23
GEM Premier ChemSTAT · CGAFDA · 2023-01-27
HemosIL von Willebrand Factor Antigen · GGPFDA · 2022-12-09
HemosIL Liquid Anti-Xa · KFFFDA · 2022-10-04
HemosIL ReadiPlasTin · GJSFDA · 2022-08-16
GEM Premier 5000 · CHLFDA · 2021-08-20
HemosIL Liquid Anti-Xa · QLUFDA · 2020-09-17
HemosIL von Willebrand Factor Antigen · GGPFDA · 2020-08-19
GEM Premier ChemSTAT · JFYFDA · 2019-02-16
GEM Premier ChemSTAT · JGSFDA · 2019-02-16
GEM Premier ChemSTAT · CGAFDA · 2019-02-16
HemosIL Factor XII Deficient Plasma · GJTFDA · 2018-03-22
GEM Premier 5000 · CHLFDA · 2017-12-29
HemosIL D-Dimer HS 500 · DAPFDA · 2017-11-22
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls · LCOFDA · 2017-09-08
ACL AcuStar · JPAFDA · 2017-03-03
GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) · CGAFDA · 2016-12-14
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) · CHLFDA · 2016-12-14
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) · GKFFDA · 2016-12-14
GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator · JGSFDA · 2016-12-14
HemosIL D-Dimer HS · DAPFDA · 2016-10-27
GEM Premier 3000 · CGAFDA · 2016-09-14
HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls · LCOFDA · 2016-07-08
HemosIL Silica Clotting Time · GFOFDA · 2016-03-16

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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