Ortho Clinical Diagnostics India Private Limited
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 113 |
| Class B | Low–moderate risk | 404 |
| Class C | Moderate–high risk | 213 |
| Class D (high risk) | Highest-risk devices | 117 |
CDSCO device licences
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 SwitzerlandThe 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 KingdomFor 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 KingdomFor 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 StatesFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomThe 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 StatesThe 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 StatesThe 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 StatesFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomQualitative 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 Kingdomlaboratory 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomQualitative 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 KingdomQualitative 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 KingdomFor 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 KingdomQualitative 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 KingdomFor 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 KingdomQualitative 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomFor 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 KingdomGlobal 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.