CDSCO UID MFG/IVD/2020/000043_b208f675e4913e990af2ec87bf67a7b1_757e8386c4aa38b5dad47fedeec644f2
Rapid Test for Syphilis (SEROCHECK Tp )
ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: CA 15-3
Registration details
- UID
- MFG/IVD/2020/000043_b208f675e4913e990af2ec87bf67a7b1_757e8386c4aa38b5dad47fedeec644f2
- Device class
- Class C
- Brand name
- CA 15-3
- Approving authority
- Sub Zonal Goa
- Product information
- Serocheck Tp (CA 15-3) is a modified TPHA, which qualitatively detects the presence of IgM and IgG class of Treponema specific antibodies during syphilis in serum or plasma specimens
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About this record
Rapid Test for Syphilis (SEROCHECK Tp ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_b208f675e4913e990af2ec87bf67a7b1_757e8386c4aa38b5dad47fedeec644f2. 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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