Product code OIH

Device name

Yersinia Spp. Reagents

Medical specialty

Unknown

Device class

U

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset