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Antibodies, Outer-Membrane Proteins

FDA product code OKM · 1 cleared devices

Class 2 Immunology
Regulation
21 CFR 866.5785
Review panel
IM
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2008-10-27 – 2008-10-27

For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.

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