BIOMERIEUX INDIA PVT. LTD.
Risk-class mix (CDSCO)
| Class A (low risk) | Lowest-risk devices | 14 |
| Class B | Low–moderate risk | 469 |
| Class C | Moderate–high risk | 131 |
| Class D (high risk) | Highest-risk devices | 7 |
CDSCO device licences
Selective chromogenic medium for the detection and differentiation of Enterococcus faecium and E. faecalis showing acquired vancomycin resistance (VRE)
IMP/IVD/2020/000873 · from FranceFor Isolation, enumeration and direct and presumptive identification of urinary tract infection organisms
IMP/IVD/2020/000873 · from FranceChromogenic medium for the screening of methicillin-resistant Staphylococcus aureus (MRSA)
IMP/IVD/2020/000873 · from FranceIsolation of micro-organisms of the urinary tract
IMP/IVD/2020/000873 · from FranceIsolation of fastidious bacteria.
IMP/IVD/2020/000873 · from FranceIsolation of fastidious bacteria and dection of hemolysis.
IMP/IVD/2020/000873 · from FranceStudy of antimicrobial susceptibility
IMP/IVD/2020/000873 · from FranceSelective isolation of enterobacteria and Escherichia coli
IMP/IVD/2020/000873 · from FranceSelective chromogenic medium for the screening of Extended Spectrum ?-Lactamase-producing enterobacteria (ESBL)
IMP/IVD/2020/000873 · from FranceSusceptibility of pneumococci and other streptococci to antibiotics
IMP/IVD/2020/000873 · from FranceThe VITEK® 2 Gram-negative Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic Gram-negative bacilli to antimicrobi…
IMP/IVD/2019/000035 · from United StatesThe VITEK® 2 Fungal Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed…
IMP/IVD/2019/000035 · from United StatesThe VITEK® REVEAL? AST System is an automated system for quantitative and qualitative antimicrobial susceptibility testing (AST) of organisms direct from positive blood culture. The VITEK® REVEAL? AST System does not provide organism identi…
IMP/IVD/2026/000042 · from United StatesThe VITEK® REVEAL? Instrument is a benchtop incubator that processes up to four AST disposables. Installation and operating details for the VITEK® REVEAL? Instrument are provided in this manual.
IMP/IVD/2019/000035 · from United StatesThe Specific Diagnostics VITEK® REVEAL? SEALER provides the heat welding of the VITEK® REVEAL? SENSOR PANEL to the AST PANEL. The VITEK® REVEAL? SEALER is a benchtop device that is used to assemble the AST Sensor and Drug Plates, forming th…
IMP/IVD/2019/000035 · from United StatesMTB-RIF/INH R-GENE Kit is an in-vitro diagnostic assay for simultaneous detection of Rifampicin and Isoniazid resistance determining mutations in mycobacterium tuberculosis positive sputum and culture samples by using Real-Time PCR after nu…
MFG/IVD/2025/000167MTBc/NTM R-GENE kit is an in-vitro diagnostic assay for simultaneous detection and differentiation of Mycobacterium tuberculosis Complex (MTBc) with Nontuberculous mycobacteria (NTM) in sputum samples and cultures, using Real-Time PCR after…
MFG/IVD/2025/000167Etest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antifungal agents against microorganisms and/or for detection of resistance mechanisms
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antimicrobial agent…
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antimicrobial agent…
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceVITEK® MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS PRIME sys…
IMP/IVD/2025/000128 · from United StatesEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceEtest is a manual quantitative technique for determining the MIC of antimicrobial agents against microorganisms and/or for detection of resistance mechanisms.
IMP/IVD/2019/000303 · from FranceGlobal 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.