OIH

Yersinia Spp. Reagents

Product code

OIH

Device name

Yersinia Spp. Reagents

Device class

Class U

Medical specialty

Unknown

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Yersinia spp. reagents are devices that consist of Serological Reagents and Nucleic Acid Amplification Reagents to differentiate Yersinia spp. and presumptively identify Yersinia pestis (Y. pestis) from cultured isolates or clinical specimens. They are indicated for use as an aid in the laboratory of diagnosis of plague.

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