Pure Global

CK-MB, Myoglobin and Troponin I cardiac marker IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

CK-MB, Myoglobin and Troponin I cardiac marker IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_3ce2d429515a978093d247ad60bb3df7_e57f97696040cd2494e44ccc98036e51. This device is marketed under the brand name Quidel Triage® Total 5 Control 2. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
CK-MB, Myoglobin and Troponin I cardiac marker IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2023/000472_3ce2d429515a978093d247ad60bb3df7_e57f97696040cd2494e44ccc98036e51

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Cardiac Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of creatine kinase MB (Quidel Triage® Total 5 Control 2), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (Quidel Triage® Total 5 Control 2)

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (10)
Other products with the same name or brand

Troponin I IVD, Control

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

Troponin I IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

Troponin I IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit,fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

BNP, CK-MB, Troponin I, D-dimer and Myoglobin cardiac marker IVD, control

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

BNP and Troponin I cardiac marker IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

Troponin I, BNP and D-dimer cardiac marker IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C

BNP, CK-MB and Troponin I cardiac marker IVD, control

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

Class C