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Enzyme Linked Immunosorbent Assay for detection of antibodies to HCV in human serum or plasma - India CDSCO Medical Device Registration

Enzyme Linked Immunosorbent Assay for detection of antibodies to HCV in human serum or plasma is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000113_5984d8cbd792a28e0ba0fadd2d50b186_ef36e55fb8b8a814a680ae9581c4e9d4. This device is marketed under the brand name Device. The license holder is QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Goa.

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CDSCO Registered
Class Class D
Enzyme Linked Immunosorbent Assay for detection of antibodies to HCV in human serum or plasma
UID: MFG/IVD/2021/000113_5984d8cbd792a28e0ba0fadd2d50b186_ef36e55fb8b8a814a680ae9581c4e9d4

Brand Name

Device

Device Class

Class D

Approving Authority

Sub Zonal Goa

Product Information

Qualisa HCV is a third generation ELISA intended to be used for the detection of antibodies to HCV in human serum / plasma,4th Generation Chemiluminescence Assay for the Detection of Antigens and Antibodies to HIV 1 & 2 Virus in Human Serum or Plasma(Device)-ELECTRA HIV Ag/Ab 4.0 CLIA is intended to be used for the detection of antibodies to HIV 1 & 2 & โ€œOโ€ subtype virus and HIV-1 p24 antigen in human serum or plasma

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