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Yersinia Spp. Reagents

OIH · Unclassified · Unknown

Classification

FDA Product Code
OIH
Device class
Unclassified
Regulation
Review panel
MI
Medical specialty
Unknown
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
1
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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