Roche Diagnostics India Pvt. Ltd.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 441 |
| Class B | Low–moderate risk | 977 |
| Class C | Moderate–high risk | 907 |
| Class D (high risk) | Highest-risk devices | 107 |
CDSCO device licences
CD68 (SP251v18) Rabbit Monoclonal Antibody is intended for laboratory use in the qualitative immunohistochemical detection of CD68 by light microscopy in sections of formalin-fixed, paraffin-embedded tissue stained on a BenchMark IHC/ISH in…
IMP/IVD/2019/000126 · from United StatesPreciControl Rubella IgM is used for quality control of the Elecsys Rubella IgM immunoassay on cobas e immunoassay analyzers.
IMP/IVD/2018/000038 · from GermanyPD-1 (NAT105) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PD-1 protein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark IHC/ISH ins…
IMP/IVD/2025/000082 · from United StatesGlypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark I…
IMP/IVD/2025/000082 · from United StatesMammaglobin (31A5) Rabbit Monoclonal Antibody is intended for laboratory use in the detection of the mammaglobin glycoprotein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark I…
IMP/IVD/2025/000082 · from United StatesTdT Rabbit Polyclonal Antibody is intended for laboratory use in the detection of TdT in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark IHC/ISH instruments. This product should…
IMP/IVD/2025/000082 · from United StatesRenal Cell Carcinoma (PN-15) Mouse Monoclonal Antibody is intended for laboratory use in the detection of the GP200 glycoprotein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMar…
IMP/IVD/2025/000082 · from United StatesGlial Fibrillary Acidic Protein (EP672Y) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glial Fibrillary Acidic Protein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immu…
IMP/IVD/2025/000082 · from United StatesCD1a (EP3622) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the detection of the CD1a glycoprotein in formalin-fixed, paraffin embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark IHC/I…
IMP/IVD/2025/000082 · from United StatesEp-CAM/Epithelial Specific Antigen (Ber-EP4) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Ep-CAM glycoprotein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistoch…
IMP/IVD/2025/000082 · from United StatesPhosphohistone H3 (PHH3) Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the Phosphohistone H3 (PHH3) protein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistr…
IMP/IVD/2025/000082 · from United StatesSOX-11 (MRQ-58) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the SOX-11 protein in formalin-fixed, paraffin-embedded human tissue stained in qualitative immunohistochemistry (IHC) on BenchMark IHC/ISH…
IMP/IVD/2025/000082 · from United StatesThe VENTANA HER2 Dual ISH DNA Probe Cocktail is intended to determine HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17 by light microscopy. The HER2 and Chromosome 17 probes are detected using two-color chromog…
IMP/IVD/2020/000627 · from United StatesVENTANA PD-L1 (SP142) Assay is intended for the immunohistochemical assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor infiltrating immune cells in formalin-fixed, paraffin-embedded (FFPE) tumor tissue stai…
IMP/IVD/2020/000627 · from United StatesVENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody is intended for laboratory use in the qualitative detection of ROS1 protein in formalin-fixed, paraffin-embedded tissue stained with VENTANA BenchMark IHC/ISH instruments. This product…
IMP/IVD/2020/000627 · from GermanyVentana Medical Systems? (Ventana) ultraView SISH DNP Detection Kit is an indirect, biotin-free system for detecting DNP labeled probes. The kit is intended to identify targets by silver in situ hybridization (ISH) in sections of formalin f…
IMP/IVD/2020/000627 · from Germany"Ventana Medical Systems, Inc.'s (Ventana) INFORM Kappa Probe is intended to detect cytoplasmic mRNA for kappa immunoglobulin light chain in formalin-fixed, paraffin-embedded tissue samples. It is typically used in conjunction with the INFO…
IMP/IVD/2020/000627 · from United States"Ventana Medical Systems, Inc.'s (Ventana) INFORM Cytoplasmic Lambda mRNA Probe (INFORM Lambda Probe) is intended to detect cytoplasmic mRNA for lambda immunoglobulin light chain in formalin fixed, paraffin embedded tissue samples. It is ty…
IMP/IVD/2020/000627 · from Germany"Ventana Medical Systems, Inc.?s (Ventana) INFORM EBER (Epstein-Barr Virus Early RNA) Probe (INFORM EBER Probe) is intended to identify, by in situ hybridization (ISH) and light microscopy, cells expressing Epstein-Barr encoded RNA (EBER) i…
IMP/IVD/2020/000627 · from GermanyVENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (VENTANA anti-ALK (D5F3)) is intended for laboratory use in the detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung ca…
IMP/IVD/2020/000627 · from GermanyThe cobas® microbial inactivation kit is to be used in conjunction with the cobas® MTB test on cobas® 6800 and cobas® 8800 Systems
IMP/IVD/2019/000461 · from GermanyThe cobas® eplex system is an automated in vitro diagnostic device designed to perform multiplexed nucleic acid tests for the simultaneous detection and identification of target nucleic acid sequences by processing single-use test cartridge…
IMP/IVD/2026/000028 · from SwitzerlandThe Alcian Blue Staining Kit is intended for laboratory use as a qualitative histologic stain to demonstrate weakly acidic mucopolysaccharides by light microscopy in sections of formalin-fixed, paraffin-embedded (FFPE) tissue stained on a B…
IMP/IVD/2019/000126 · from United StatesThe Diastase Kit, in conjunction with the PAS Stain Core Kit or the PAS Staining Kit, is intended for laboratory use as a digestion reagent for glycogen in sections of formalin-fixed, paraffin-embedded (FFPE) tissue stained on a BenchMark S…
IMP/IVD/2019/000126 · from United StatesMucicarmine Staining Kit is intended for use as a qualitative histologic stain to detect acid mucopolysaccharides (mucin) in formalin-fixed, paraffin-embedded tissue. This product should be interpreted by a qualified pathologist in conjunc…
IMP/IVD/2019/000126 · from United StatesAlcian Blue for PAS, in conjunction with the PAS Staining Kit OR the PAS Stain Core Kit, is intended for laboratory use as a qualitative histologic stain to differentiate between acid and neutral mucins by light microscopy in sections of fo…
IMP/IVD/2019/000126 · from United StatesBenchMark Special Stains Cleaning Kit is intended for use during the automated cleaning procedure on the BenchMark Special Stains instrument. This product is intended for in vitro diagnostic (IVD) use.
IMP/IVD/2019/000126 · from United StatesThe Iron Staining Kit is intended for laboratory use as a qualitative histologic stain to demonstrate iron pigment by light microscopy in sections of formalin-fixed, paraffin-embedded (FFPE) tissue stained on a BenchMark Special Stains inst…
IMP/IVD/2019/000126 · from United StatesLight Green for PAS is intended for laboratory use in staining non-target tissue components and providing contrast with target stains in sections of formalin-fixed, paraffin-embedded (FFPE) tissue on a BenchMark Special Stains instrument. T…
IMP/IVD/2019/000126 · from United StatesIn vitro test for the quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in whole blood or hemolysate on cobas c systems. HbA1c determinations are useful for monitoring of long?term blood glucose c…
IMP/IVD/2018/000038 · from GermanyRoche Cell Collection Medium is designed for the preservation and transport of cells to be used in molecular testing and/or for the preparation of cytology slides.
IMP/IVD/2021/000031 · from GermanyThe LumiraDx Instrument (hereafter referred to as Instrument) is intended for use with the LumiraDx family of Test Strips (hereafter referred to as Test Strips) for the in vitro measurement of various analytes in a range of biological sam…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx Multi Quality Controls are intended for use by laboratory professionals/healthcare professionals for automated liquid quality control testing performed on the LumiraDx Instrument when used with the following test strips: ? Lu…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx CRP Test Strips are intended for use with the LumiraDx Instrument. It is an automated in vitro diagnostic test for near-patient testing, for use by healthcare professionals, for the quantitative determination of C-Reactive P…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx D-Dimer test is an in vitro diagnostic test for the quantitative determination of D-Dimer in human capillary and venous whole blood and plasma samples (Sodium Citrate). The LumiraDx D-Dimer Test Strips are intended for use w…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx NT-proBNP Quality Controls are intended for use by laboratory professionals/healthcare professionals for automated quality control testing performed on the LumiraDx Instrument when used with the LumiraDx NT-proBNP Test Strip.…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx HbA1c Quality Controls are intended for use by laboratory professionals/healthcare professionals for automated quality control testing performed on the LumiraDx Instrument when used with the LumiraDx HbA1c test Strip. The Qua…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx HbA1c test is an in vitro diagnostic test for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human capillary and venous whole blood samples (EDTA). The LumiraDx HbA1c Test Strips are intended f…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx INR Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx INR Test Strip. The Quality Controls provide users with assurance that the device is performi…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx NT-proBNP test is an in vitro diagnostic test for the quantitative determination of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) in human capillary and venous whole blood and plasma samples (Lithium Heparin). The Lum…
IMP/IVD/2025/000185 · from United KingdomThe LumiraDx INR Test Strips are intended for use with the LumiraDx Instrument. It is for use by healthcare professionals for quantitative prothrombin time testing, reported as International Normalized Ratio (INR), for the monitoring of…
IMP/IVD/2025/000185 · from United KingdomThe cobas" TaqScreen MPX Test, version 2.0 (v2.0) for use with the cobas s 201 system, is a qualitative in vitro test for the direct detection of Human Immunodeficiency Virus Type I (HIV-I) Group M RNA, HIV-I Group O RNA, Human Immunodef…
IMP/IVD/2019/000361 · from United Statescobas TaqScreen MPX Control Kit, v 2.0 is used in conjunction with cobas TaqScreen MPX Test, v 2.0
IMP/IVD/2019/000361 · from United StatesUniversal Control P is used for quality control of Roche coagulation assays on the indicated cobas t analyzers.
IMP/IVD/2018/000038 · from GermanyUniversal Control N is used for quality control of Roche coagulation assays on the indicated cobas t analyzers.
IMP/IVD/2018/000038 · from GermanyUniversal Calibrator is used for calibration of Roche coagulation assays on indicated cobas t analyzers.
IMP/IVD/2018/000038 · from GermanyIn vitro test for the quantitative determination of C reactive protein (CRP) in human serum and plasma on cobas c systems. CRP measurements, performed with this assay, in human serum or plasma, are used as aid in diagnosis, monitoring, prog…
IMP/IVD/2018/000038 · from Germanycobas® HPV Positive Control Kit is used to monitor for failures of rRT-PCR reagents and reaction conditions. Pack insert updated for self-sampling claim for HPV.
IMP/IVD/2019/000361 · from United StatesCell Wash Solution I/ NaOH-D is used as alkaline wash solution for reaction cells on Roche/Hitachi systems.
IMP/IVD/2020/000037 · from ChinaSystem solution for cleaning the detection unit of Elecsys or cobas e immunoassay analyzers.
IMP/IVD/2020/000037 · from GermanyGlobal footprint
Cross-railThe same manufacturer across regulators — 619 FDA clearances, 0 flagged adverse-event signals.
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.