LJB

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Product code

LJB

Device name

Enzyme Linked Immunoabsorbent Assay, Rubeola Igg

Device class

Class 1

21 CFR

21 CFR 866.3520

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

The qualitative detection of measles specific IgG antibodies in serum or plasma.

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