H. PYLORI ANTIBODY RAPID TEST KIT - India CDSCO Medical Device Registration

H. PYLORI ANTIBODY RAPID TEST KIT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000057_a1da077034e5219ad1ff689befedbc16_21d7b3f9ba8baf311ff97bb250131fa2. This device is marketed under the brand name Generic. 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

H. PYLORI ANTIBODY RAPID TEST KIT

UID: MFG/IVD/2021/000057_a1da077034e5219ad1ff689befedbc16_21d7b3f9ba8baf311ff97bb250131fa2

Brand Name

Generic

License Holder

Recombigen Laboratories Pvt Ltd

Device Class

Class B

Approving Authority

North Delhi Division

Product Information

The H. Pylori Antibody Rapid Test Kit (Generic) is a rapid visual immunoassay for the qualitative detection of specific IgM, IgG and IgA antibodies to Helicobacter pylori in human serum, plasma or whole blood specimens. This kit is intended for use as an aid in the diagnosis of H. pylori infection.