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CRP REAGENT KIT - India CDSCO Medical Device Registration

CRP REAGENT KIT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000072_ed488f54d2227e957b4bcb22995a8037_759034ad63048f1595976b1514f2bd62. This device is marketed under the brand name Ultichem. The license holder is Yucca Diagnostics, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered
Class Class B
CRP REAGENT KIT
UID: MFG/IVD/2022/000072_ed488f54d2227e957b4bcb22995a8037_759034ad63048f1595976b1514f2bd62

Brand Name

Ultichem

License Holder

Yucca Diagnostics

Device Class

Class B

Approving Authority

Pune Division

Product Information

CRP Kit is liquid stable reagent kit for the quantitative determination of CRP in human Serum based on IMMUNO TURBIDIMETRIC Method. Test kit contains liquid stable REAGENT 1 & REAGENT 2 which is manufactured using TRIS BUFFER and CRP ANTI HUMAN CRP ANTIBODIES along with standard chemicals using the established manufacturing procedures. Reagent contains Stabilizer, excipients and surface active agents along with distilled water. The reagents are dispensed into HDPE containers and are labelled and assembled into a reagent kit box along with the package insert

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