CDSCO UID MFG/IVD/2021/000113_af9893bdb6a256ed605a0b610e68f247_67368f6897a6ca0d0f369dd3f22ac153
Enzyme Linked Immunosorbent Assay for detection of antibodies to HIV 1 and 2 in human serum or plasma
QUALPRO DIAGNOSTICS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class D·India CDSCO·Brand: Device
Registration details
- UID
- MFG/IVD/2021/000113_af9893bdb6a256ed605a0b610e68f247_67368f6897a6ca0d0f369dd3f22ac153
- Device class
- Class D
- Brand name
- Device
- Approving authority
- Sub Zonal Goa
- Product information
- Qualisa HIV 1 & 2 is intended to be used for the detection of antibodies to HIV-1 & HIV-2 in human serum or plasma,: Fourth Generation Enzyme Linked Immunosorbent Assay (Device) for detection of antibodies to HIV 1 and 2 and “O’ subtypes and HIV-1 p24 antigen in human serum or plasma(Device)-Qualisa HIV 4.0 is intended to be used for the detection of antibodies to HIV-1 & HIV-2 & O subtypes and p24 antigen in human serum or plasma
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About this record
Enzyme Linked Immunosorbent Assay for detection of antibodies to HIV 1 and 2 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_af9893bdb6a256ed605a0b610e68f247_67368f6897a6ca0d0f369dd3f22ac153. 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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