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One Step FOB Fecal Occult Blood Rapid Test Kit - India CDSCO Medical Device Registration

One Step FOB Fecal Occult Blood Rapid Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000111_dc3a6c32f2a20451c92e6927007d1c35_93319de1e45234128096013a0b921d81. This device is marketed under the brand name Mediline-SA. The license holder is S.A-MEDLINE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
One Step FOB Fecal Occult Blood Rapid Test Kit
UID: MFG/IVD/2023/000111_dc3a6c32f2a20451c92e6927007d1c35_93319de1e45234128096013a0b921d81

Brand Name

Mediline-SA

Device Class

Class C

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

The test kit is designed for the qualitative detection of human occult blood in feces according to the principle of gold immunochromatography assay. Feces detection is a common indicator of digestive tract diseases, and is very important in the diagnosis of digestive tract diseases. The detection of gastrointestinal bleeding is an effective method to find occult blood and one of the important means for clinical diagnosis and monitoring of digestive tract hemorrhage disease. It is a cautionary tale for the early screening of the colorectal diseases in asymptomatic patients

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