Syphilis Rapid Diagnostic Test Kit - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class D

Syphilis Rapid Diagnostic Test Kit

UID: MFG/IVD/2022/000164_e550a94bd68078c9ab510a79ae195f1f_f43571a21c257f177eb92a3e24e3206a

Brand Name

AccuTest HBsAg Rapid Diagnostic Test Kit

License Holder

Accurex Biomedical Pvt Ltd

Device Class

Class D

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.