HCG Serum/Plasma/Urine - India CDSCO Medical Device Registration

HCG Serum/Plasma/Urine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000052_e10e4e82120c6a870adb9cfcc058f611_f7950f8605da3d69838dab981acf8e7f. This device is marketed under the brand name Clear & Sure. The license holder is Recombigen Laboratories Pvt Ltd, and it is classified as Device Class Class B. The approving authority is North Delhi Division.

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CDSCO Registered

Class Class B

HCG Serum/Plasma/Urine

UID: MFG/IVD/2021/000052_e10e4e82120c6a870adb9cfcc058f611_f7950f8605da3d69838dab981acf8e7f

Brand Name

Clear & Sure

License Holder

Recombigen Laboratories Pvt Ltd

Device Class

Class B

Approving Authority

North Delhi Division

Product Information

The proposed IVD product is a “HCG (Clear & Sure) in plastic cassette format”. It is intended for qualitative detection of HCG (Clear & Sure) in human serum, plasma and whole blood sample