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Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma - India CDSCO Medical Device Registration

Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_d7f59bfd5a77dbf445ecff5bad4178d0_bd3c9ff5d452c2cc69d803b1d78ec52d. This device is marketed under the brand name CA 15-3. The license holder is ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Goa.

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CDSCO Registered
Class Class C
Fluorescence Immunoassay for Quantitative detection of Prostate Specific Antigen in Human Serum/Plasma
UID: MFG/IVD/2020/000043_d7f59bfd5a77dbf445ecff5bad4178d0_bd3c9ff5d452c2cc69d803b1d78ec52d

Brand Name

CA 15-3

Device Class

Class C

Approving Authority

Sub Zonal Goa

Product Information

FIACHECK PSA Fluorescence Immunoassay is intended for the in-vitro quantitative measurement of Prostate Specific Antigen (CA 15-3) in human serum and plasma

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