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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device yersinia spp. reagents
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.
Product CodeOIH
Device Class Unclassified