Syphilis Rapid Diagnostic Test Kit
- UID
- MFG/IVD/2022/000164_e550a94bd68078c9ab510a79ae195f1f_f43571a21c257f177eb92a3e24e3206a
- Device class
- Class D
- Brand name
- AccuTest HBsAg Rapid Diagnostic Test Kit
- License holder
- Accurex Biomedical Pvt Ltd
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- AccuTest Syphilis is intended to be used for qualitative detection of Treponemal antibodies (AccuTest HBsAg Rapid Diagnostic Test Kit) generated against Treponema pallidum Antigens (AccuTest HBsAg Rapid Diagnostic Test Kit) in human serum or plasma with high sensitivity and specificity.
Syphilis Rapid Diagnostic Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000164_e550a94bd68078c9ab510a79ae195f1f_f43571a21c257f177eb92a3e24e3206a. This device is marketed under the brand name AccuTest HBsAg Rapid Diagnostic Test Kit. The license holder is Accurex Biomedical Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.
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