Importer / authorised agent · Telangana · India

Thermo Fisher Scientific 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

1,240

Manufacturing

0

Import

1,240

FDA clearances

64

Risk-class mix (CDSCO)

Class A (low risk)	Lowest-risk devices	48
Class B	Low–moderate risk	952
Class C	Moderate–high risk	240
Class D (high risk)	Highest-risk devices	0

CDSCO device licences

ImmunoCAP Allergen f216, Cabbage · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f24, Shrimp · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f18, Brazil nut · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f215, Lettuce · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f221, Coffee · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f245, Egg · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e85, Chicken feathers · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f17, Hazel nut · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f20, Almond · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f214, Spinach · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f218, Paprika, Sweet pepper · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e213, Parrot feathers · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e215, Pigeon feathers · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f244, Cucumber · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e4, Cow dander · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e82, Rabbit epithelium · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f12, Pea · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f15, White bean · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f201, Pecan nut · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f208, Lemon · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f210, Pineapple · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f212, Mushroom (champignon) · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e3, Horse dander · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e6, Guinea pig epithelium · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e1, Cat dander · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen d3, House dust mite · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c261, Pholcodine · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c1, Penicilloyl G · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f235, Lentil · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f23, Crab · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c260, Morphine · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen d201, House dust mite · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e5, Dog dander · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen e71, Mouse epithelium · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen ex1, Animal proteins · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f10, Sesame seed · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f13, Peanut · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f14, Soybean · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen d1, House dust mite · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f1, Egg white · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f202, Cashew nut · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f203, Pistachio · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c5, Ampicilloyl · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c8, Chlorhexidine · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c73, Insulin human · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c6, Amoxicilloyl · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c202, Suxamethonium (Succinylcholine) · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen d2, House dust mite · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen c2, Penicilloyl V · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

ImmunoCAP Allergen f254, Plaice · Class BIMPORT · 2026-04-22

ImmunoCAP Specific IgE is an in vitro test system for the quantitative measurement of allergen specific IgE in human serum or plasma. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic di…

IMP/IVD/2019/000475 · from Sweden

Global footprint

Cross-rail

The same manufacturer across regulators — 64 FDA clearances, 0 flagged adverse-event signals.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL · JWYFDA · 2025-09-25

The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL · JWYFDA · 2025-09-05

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL · JWYFDA · 2025-08-28

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL · JWYFDA · 2025-06-30

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. · JWYFDA · 2025-06-20

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL · JWYFDA · 2025-05-22

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL · JWYFDA · 2025-04-15

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL · NGZFDA · 2025-02-27

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL · JWYFDA · 2025-02-10

The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL · JWYFDA · 2025-02-10

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL · JWYFDA · 2024-12-19

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL · JWYFDA · 2024-12-05

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL · JWYFDA · 2024-11-26

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. · JWYFDA · 2024-10-09

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. · JWYFDA · 2024-10-01

The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. · JWYFDA · 2024-05-16

Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml · JWYFDA · 2023-10-31

The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL · NGZFDA · 2023-08-31

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml · JWYFDA · 2023-08-30

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL · JWYFDA · 2023-08-25

Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) · JWYFDA · 2023-06-30

Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) · JWYFDA · 2023-03-21

Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL · NGZFDA · 2023-03-10

The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml · NGZFDA · 2023-01-20

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml · JWYFDA · 2021-12-20

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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