Saudi Arabia SFDA registration ME0000001030SFDAA00222
bioNexia® FOBplus
Saudi Arabia·Chemicals·BIOMERIEUX S.A.·General IVD(Others)ActiveProduct information
Test for detection of human hemoglobin in stools
Product use
The bioNexia® FOBplus (Fecal Occult Blood) and the bioNexia® FOBplus LK are rapid test for qualitative detection of human hemoglobin in stools. The test is intended for professional in vitro diagnostic use only.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001030SFDAA00222
- Authorization ID
- GHTF-2019-0890
- Status
- Active
- Expire Date
- August 02, 2022
Manufacturer
- Manufacturer Name
- BIOMERIEUX S.A.
Model information
- Model ID(s)
- 410594, 414275, 414276
Product accessories
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About this record
Access comprehensive regulatory information for bioNexia® FOBplus in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000001030SFDAA00222 and manufactured by BIOMERIEUX S.A..
This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
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