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CKMB Rapid Test - India CDSCO Medical Device Registration

CKMB Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000106_1bc1f952e92c642fc991e18948345629_4f9ef1bbbdc38827fc7ae060b4da255e. This device is marketed under the brand name hCG. The license holder is Medlera Healthcare, and it is classified as Device Class Class B. The approving authority is Gujarat.

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.

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CDSCO Registered
Class Class B
CKMB Rapid Test
UID: MFG/IVD/2023/000106_1bc1f952e92c642fc991e18948345629_4f9ef1bbbdc38827fc7ae060b4da255e

Brand Name

hCG

License Holder

Medlera Healthcare

Device Class

Class B

Approving Authority

Gujarat

Product Information

The CKMB rapid test kit is a rapid immunochromatography assay for the qualitative detection of Creatine Kinase MB (hCG) in human whole blood, serum, plasma samples to aid in the diagnosis of myocardial infarction (hCG)

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