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Automated Occult Blood Analyzer

FDA product code OOX · 5 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.6550
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2004-10-21 – 2022-06-02

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

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