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CK-MB Test - India CDSCO Medical Device Registration

CK-MB Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000413_72ae464238a0a5d47eff03f29a7feb9a_e7d7af1e65353a75321b382727697d2a. This device is marketed under the brand name Finecare Beta-HCG Rapid Quantitative Test. The license holder is Star Biomed Pvt. Ltd., and it is classified as Device Class Class B. 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.

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CDSCO Registered
Class Class B
CK-MB Test
UID: IMP/IVD/2021/000413_72ae464238a0a5d47eff03f29a7feb9a_e7d7af1e65353a75321b382727697d2a

Brand Name

Finecare Beta-HCG Rapid Quantitative Test

License Holder

Star Biomed Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Finecareโ„ข CK-MB Rapid Quantitative Test is a fluorescence immunoassay used along with Finecareโ„ข FIA System (Finecare Beta-HCG Rapid Quantitative Test) for quantitative determination of Creatine Kinase-MB (Finecare Beta-HCG Rapid Quantitative Test) in human whole blood, serum or plasma

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