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Serum Protein Multi-Calibrator 2 - India CDSCO Medical Device Registration

Serum Protein Multi-Calibrator 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000040_cdc58a8b70da597d61bdbc17ba92213c_90b256b2a52ec1467c96712db7728feb. This device is marketed under the brand name COULTER LH Series Pak Reagent Kit. The license holder is Beckman Coulter India Private Limited, 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
Serum Protein Multi-Calibrator 2
UID: IMP/IVD/2019/000040_cdc58a8b70da597d61bdbc17ba92213c_90b256b2a52ec1467c96712db7728feb

Brand Name

COULTER LH Series Pak Reagent Kit

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Serum Protein Multi-Calibrator 2 is intended to be used with the Beckman Coulter immuno-turbidimetric reagents listed in the IFU for the quantitative determination of ฮฑ-1 acidglycoprotein, ฮฑ-1 antitrypsin, ฮฒ-2 microglobulin, ceruloplasmin and haptoglobin on Beckman Coulter analysers. The material is prepared from human serum with the constituent values adjusted where necessary by the addition of analytical grade chemicals and appropriate serum proteins

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