OKM

Antibodies, Outer-Membrane Proteins

Product code

OKM

Device name

Antibodies, Outer-Membrane Proteins

Device class

Class 2

21 CFR

21 CFR 866.5785

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).