Importer / authorised agent · Maharashtra · India

Ortho Clinical Diagnostics 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
847
Manufacturing
0
Import
847
FDA clearances
0

Risk-class mix (CDSCO)

Class A (low risk)Lowest-risk devices113
Class BLow–moderate risk404
Class CModerate–high risk213
Class D (high risk)Highest-risk devices117

CDSCO device licences

Laboratory Automation System · Class AIMPORT · 2026-03-11

FlexLab X is a modular system designed to automate Pre- Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory.

IMP/IVD/2026/000029 · from Switzerland
Blood Grouping Reagents (Newborn DVI Cassette) · Class DIMPORT · 2026-02-09

The Ortho BioVue® System Newborn DVI Cassette comprised of Anti-A (AntiABO1) (Monoclonal) / Anti-B (Anti-ABO2) (Monoclonal) / Anti-A,B (Anti-ABO3) (Monoclonal) / Anti-D(DVI) (Anti-RH1) (Monoclonal) / Control, and Anti-IgG (Rabbit) (Green) r…

IMP/IVD/2019/000135 · from United Kingdom
Progesterone 2 Calibrators · Class BIMPORT · 2025-11-25

For in vitro diagnostic and laboratory professional use. For use in the calibration of the automated VITROS Immunodiagnostic Systems and the VITROS Integrated Systems for the quantitative measurement of progesterone in human serum and plas…

IMP/IVD/2025/000164 · from United Kingdom
Progesterone 2 Reagent Pack · Class BIMPORT · 2025-11-25

For in vitro diagnostic and laboratory professional use. VITROS Immunodiagnostic Products Progesterone 2 Reagent Pack quantitatively measures progesterone in human serum and plasma (EDTA or heparin) using the automated VITROS Immunodiagnos…

IMP/IVD/2025/000164 · from United States
Anti-A (Anti-ABO1) (Monoclonal) / Anti-B (Anti-ABO2) (Monoclonal) / Anti-D(DVI) (Anti-RH1) (Monoclonal), Ortho BioVue® System (ABD(DVI) Donor Confirmation Cassette) · Class DIMPORT · 2025-09-08

For in vitro diagnostic and laboratory professional use. Anti-A (Anti-ABO1) (Monoclonal) / Anti-B (Anti-ABO2) (Monoclonal) / Anti-D(DVI) (Anti-RH1) (Monoclonal) Ortho BioVue® System (ABD(DVI) Donor Confirmation Cassette) is intended for man…

IMP/IVD/2019/000135 · from United Kingdom
Anti-A(Anti-ABO1) (Monoclonal)/Anti-B(Anti-ABO2) (Monoclonal)/Anti-A,B (Anti-ABO3) (Monoclonal) /Anti-D (Anti-RH1) (Monoclonal) /Anti-D(DVI)(Anti-RH1) (Monoclonal)/ Control, Ortho BioVue® System · Class DIMPORT · 2025-09-08

For in vitro diagnostic and laboratory professional use. Anti-A (Anti-ABO1) (Monoclonal) / Anti-B (Anti-ABO2) (Monoclonal) / Anti-A,B (Anti-ABO3) (Monoclonal) / Anti-D (Anti-RH1) (Monoclonal) / Anti-D(DVI) (Anti-RH1) (Monoclonal) / Control,…

IMP/IVD/2019/000135 · from United Kingdom
Anti?HCV Reagent Pack (STM) · Class DIMPORT · 2025-05-19

For In vitro Diagnostic use only. For the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma (EDTA, heparin or citrate), using the VITROS Immunodiagnostic Systems and the VITROS Integrated Systems.

IMP/IVD/2019/000135 · from United Kingdom
Anti?HCV Calibrators (STM) · Class DIMPORT · 2025-05-19

For in vitro diagnostic use only. For use in the calibration of the VITROS Immunodiagnostic Systems and Integrated Systems for the qualitative detection of antibodies to hepatitis C Virus (anti-HCV) in human serum and plasma (EDTA, heparin …

IMP/IVD/2019/000135 · from United Kingdom
Placental Growth Factor IVD, kit, fluorescent immunoassay · Class CIMPORT · 2024-10-10

The Quidel Triage® PlGF Test is a fluorescence immunoassay to be used with the Quidel Triage® Meter for the quantitative determination of Placental Growth Factor (PLGF) in EDTA anticoagulated plasma specimens.

IMP/IVD/2023/000472 · from United States
Placental Growth Factor IVD, control · Class CIMPORT · 2024-10-10

The Quidel Triage® PLGF Controls are assayed materials to be used with the Quidel Triage® PLGF Test and the Quidel Triage® Meter to assist the end user in monitoring product performance.

IMP/IVD/2023/000472 · from United States
Placental Growth Factor IVD, control · Class CIMPORT · 2024-10-10

The Quidel Triage® PLGF Controls are assayed materials to be used with the Quidel Triage® PLGF Test and the Quidel Triage® Meter to assist the end user in monitoring product performance.

IMP/IVD/2023/000472 · from United States
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack · Class CIMPORT · 2024-09-30

For in vitro diagnostic use only. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrators is a chemil…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products Anti?SARS-CoV-2 IgG Quantitative Controls · Class CIMPORT · 2024-09-30

For in vitro diagnostic and laboratory professional use. For use in monitoring the performance of the VITROS Immunodiagnostic Systems and the VITROS Integrated Systems when used with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG …

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrator · Class CIMPORT · 2024-09-30

For in vitro diagnostic use only. The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrators is a chemil…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products TSH3 Reagent Pack · Class BIMPORT · 2024-07-09

For in vitro diagnostic and laboratory professional use. For the quantitative measurement of thyroid stimulating hormone (TSH) in human serum and plasma (EDTA and Lithium heparin) using the automated suitable VITROS Immunodiagnostic Systems…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products TSH3 Calibrators · Class BIMPORT · 2024-07-09

For in vitro diagnostic and laboratory professional use. For use in the calibration of the automated suitable VITROS Immunodiagnostic Systems and the VITROS Integrated Systems for the quantitative measurement of thyroid stimulating hormone …

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack · Class CIMPORT · 2024-07-09

For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the suitable VITROS Systems to aid in the diagnosis of heart failur…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products NT-proBNP II Controls · Class CIMPORT · 2024-07-09

For in vitro diagnostic use only. For use in monitoring the performance of the Suitable VITROS Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP).

IMP/IVD/2019/000135 · from United Kingdom
hs Troponin I Low Control · Class CIMPORT · 2024-07-09

For in vitro diagnostic use only. For use in monitoring the performance of the Immunodiagnostic Systems and the Integrated Systems when used for the measurement of cardiac troponin I in human serum and plasma (heparin).

IMP/IVD/2019/000135 · from United Kingdom
hs Troponin I Assay · Class CIMPORT · 2024-07-09

For in vitro diagnostic use only. For the quantitative measurement of cardiac troponin I (cTnI) in human serum and plasma (heparin) using the Immunodiagnostic Systems and the Integrated Systems.

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products NT-proBNP II Calibrators · Class CIMPORT · 2024-07-09

For in vitro diagnostic use only. For use in the calibration of the suitable VITROS Systems for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin).

IMP/IVD/2019/000135 · from United Kingdom
hs Troponin I Calibrators · Class CIMPORT · 2024-07-09

For in vitro diagnostic use only. For use in the calibration of the Immunodiagnostic Systems and the Integrated Systems for the quantitative measurement of cardiac troponin I in human serum and plasma (heparin).

IMP/IVD/2019/000135 · from United Kingdom
Total T3 II Reagent Pack · Class BIMPORT · 2024-07-01

For in vitro diagnostic and laboratory professional use. VITROS Immunodiagnostic Products Total T3 II Reagent Pack quantitatively measures total triiodothyronine (T3) in human serum and plasma (EDTA or heparin) using the automated VITROS Im…

IMP/IVD/2019/000135 · from United Kingdom
Total T3 II Calibrators · Class BIMPORT · 2024-07-01

For in vitro diagnostic and laboratory professional use. For use in the calibration of the automated VITROS Immunodiagnostic Systems and the VITROS Integrated Systems for the quantitative measurement of total triiodothyronine (T3) in human…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) · Class DIMPORT · 2024-06-14

For in vitro diagnostic and laboratory professional use. For use in monitoring the performance of the suitable automated VITROS Systems when used for the determination of antibodies to Human Immunodeficiency Virus type 1 group O (anti-HIV-1…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) · Class DIMPORT · 2024-06-14

For in vitro diagnostic and laboratory professional use. For use in monitoring the performance of the suitable automated VITROS Systems when used for the determination of antibodies to Human Immunodeficiency Virus types 1, and/or 2 (anti-HI…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) · Class DIMPORT · 2024-06-14

For in vitro diagnostic and laboratory professional use. For use in monitoring the performance of the suitable automated VITROS Systems when used for the determination of HIV p24 antigen.

IMP/IVD/2019/000135 · from United Kingdom
Blood Grouping Reagents Anti-A (Monoclonal) Anti-B (Monoclonal) Anti-A,B (Monoclonal)Anti-D Anti-RH1)(Monoclonal)Anti-D (Anti-RH1)(Monoclonal)Control Ortho BioVue System(ABO-DD Grouping Cassettes) · Class DIMPORT · 2024-06-14

Qualitative test for recognition of the A (ABO1), B (ABO2), and D (RH1) antigens on human red blood cells. FOR IN VITRO DIAGNOSTIC USE

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack · Class CIMPORT · 2024-06-04

For in vitro diagnostic and laboratory professional use. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack, when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator, is a chemilumin…

IMP/IVD/2019/000135 · from United Kingdom
T3 Uptake II Calibrators · Class BIMPORT · 2024-06-04

For in vitro diagnostic and laboratory professional use. For use in the calibration of the automated VITROS Immunodiagnostic Systems and the VITROS Integrated Systems for the quantitative assessment of thyroid hormone binding capacity in hu…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls · Class CIMPORT · 2024-06-04

For in vitro diagnostic and laboratory professional use. For use in monitoring the performance of the VITROS Immunodiagnostic Systems and the VITROS Integrated Systems when used for the determination of antibodies to SARS-CoV-2.

IMP/IVD/2019/000135 · from United Kingdom
T3 Uptake II Reagent Pack · Class BIMPORT · 2024-06-04

laboratory professional use. VITROS Immunodiagnostic Products T3 Uptake II Reagent Pack quantitatively assesses thyroid hormone binding capacity in human serum and plasma (EDTA or heparin) using the automated VITROS Immunodiagnostic Systems…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products Anti-HTLV I/II Controls · Class CIMPORT · 2024-05-28

For in vitro diagnostic and Laboratory Professional use For use in monitoring the performance of the automated suitable VITROS Systems when used with the VITROS Immunodiagnostic Products Anti-HTLV I/II test for the determination of antibo…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products Anti-HTLV I/II Reagent Pack · Class CIMPORT · 2024-05-28

For in vitro diagnostic and Laboratory Professional use. For the in vitro qualitative detection of antibodies to human T-cell lymphotropic virus Types I and/or II, (HTLV-I and HTLV-II) in human serum and plasma (heparin, EDTA and citrate)…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products B?R?A?H?M?S PCT Controls · Class CIMPORT · 2024-05-28

For in vitro diagnostic use only. For use in monitoring the performance of the suitable VITROS Systems when used for the measurement of procalcitonin (PCT).

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products B?R?A?H?M?S PCT Calibrators · Class CIMPORT · 2024-05-28

For in vitro diagnostic use only. For use in the calibration of the suitable VITROS Systems for the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA).

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products B?R?A?H?M?S PCT Reagent Pack · Class CIMPORT · 2024-05-28

For in vitro diagnostic use only. For the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) using the suitable VITROS Systems. The VITROS B?R?A?H?M?S PCT test is indicated as an aid to be u…

IMP/IVD/2019/000135 · from United Kingdom
VITROS Immunodiagnostic Products Anti-HTLV I/II Calibrator · Class CIMPORT · 2024-05-28

For in vitro diagnostic and Laboratory Professional use. For use in the calibration of the automated suitable VITROS Systems for the qualitative determination of antibodies to HTLV I and/or II in human serum and plasma (heparin, EDTA and c…

IMP/IVD/2019/000135 · from United Kingdom
ADK Cassette · Class DIMPORT · 2024-05-15

Qualitative test for recognition of the A (ABO1), B (ABO2), D (RH1) and K (K1) antigens on human red blood cells FOR IN VITRO DIAGNOSTIC USE

IMP/IVD/2019/000135 · from United Kingdom
ABO-Rh/Reverse Grouping Cassette · Class DIMPORT · 2024-05-15

Qualitative test for determination of the ABO blood group and D (RH1) antigens on human red blood cells and for determination of expected blood group antibodies FOR IN VITRO DIAGNOSTIC USE

IMP/IVD/2019/000135 · from United Kingdom
AFP Assay · Class CIMPORT · 2024-05-15

For in vitro diagnostic use only. For the quantitative measurement of alpha-fetoprotein (AFP) using the Immunodiagnostic Systems and the Integrated Systems in (i) maternal serum, plasma (EDTA or heparin) and amniotic fluid, to aid in the d…

IMP/IVD/2019/000135 · from United Kingdom
ABD Confirmation Cassette · Class DIMPORT · 2024-05-15

Qualitative test for confirmation of the A (ABO1), B (ABO2) and D (RH1) antigens on human red blood cells FOR IN VITRO DIAGNOSTIC USE

IMP/IVD/2019/000135 · from United Kingdom
25-OH Vitamin D Assay · Class BIMPORT · 2024-05-15

For in vitro diagnostic use only. For the quantitative measurement of total 25-OH vitamin D in human serum using the Immunodiagnostic Systems and the Integrated Systems.

IMP/IVD/2019/000135 · from United Kingdom
ABO-Rh Grouping Cassette · Class DIMPORT · 2024-05-15

Qualitative test for recognition of the A (ABO1), B (ABO2), D (RH1), C (RH2) and E (RH3) antigens on human red blood cells FOR IN VITRO DIAGNOSTIC USE

IMP/IVD/2019/000135 · from United Kingdom
AFP Calibrators · Class CIMPORT · 2024-05-15

For in vitro diagnostic use only. For use in the calibration of the Immunodiagnostic Systems and the Integrated Systems for the quantitative measurement of alpha-fetoprotein (AFP) in human serum, plasma (EDTA or heparin) and amniotic flui…

IMP/IVD/2019/000135 · from United Kingdom
Anti-HBc IgM Calibrator · Class DIMPORT · 2024-05-15

For in vitro diagnostic use only. For use in the calibration of the Immunodiagnostic System and the Integrated System for the qualitative determination of IgM antibody to hepatitis B virus core antigen (HBc) in human serum and plasma (EDTA…

IMP/IVD/2019/000135 · from United Kingdom
Anti-HBs Controls · Class DIMPORT · 2024-05-15

For in vitro diagnostic use only. For use in monitoring the performance of the Immunodiagnostic System and the Integrated System when used for the measurement of anti-HBs.

IMP/IVD/2019/000135 · from United Kingdom
Signal Reagent · Class AIMPORT · 2024-05-15

For in vitro diagnostic use only For the generation of the luminescence signal on the Immunodiagnostic Systems and the Integrated Systems

IMP/IVD/2019/000135 · from United Kingdom
Anemia Controls · Class BIMPORT · 2024-05-15

For in vitro diagnostic use only. For use in monitoring the performance of the Immunodiagnostic Systems and the Integrated Systems when used for the measurement of the analytes (Ferritin and Vitamin B12)

IMP/IVD/2019/000135 · from United Kingdom
Anti-HBc IgM Assay · Class DIMPORT · 2024-05-15

For in vitro diagnostic use only. For the qualitative determination of IgM antibody to hepatitis B virus core antigen (HBc) in human serum and plasma (EDTA, heparin or citrate) using the Immunodiagnostic System and the Integrated System. …

IMP/IVD/2019/000135 · from United Kingdom

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.

Early access

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