Helicobacter pylori Antibody Rapid Test - India CDSCO Medical Device Registration

Helicobacter pylori Antibody Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000009_b8c3fb4b91b38788b0dd8453faf5eac4_2ae669f7ca895883b05afd1bdb0c63f8. This device is marketed under the brand name HI-QUIK. The license holder is Helico International, and it is classified as Device Class Class B. The approving authority is Karnataka.

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CDSCO Registered

Class Class B

Helicobacter pylori Antibody Rapid Test

UID: MFG/IVD/2019/000009_b8c3fb4b91b38788b0dd8453faf5eac4_2ae669f7ca895883b05afd1bdb0c63f8

Brand Name

HI-QUIK

License Holder

Helico International

Device Class

Class B

Approving Authority

Karnataka

Product Information

qualitative detection of antibodies to H. pylori in whole blood, serum, or plasma to aid in the diagnosis of H. pylori infection

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