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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Kit includes primers, probes, enzymes and specific controls for amplification and are designed for use with specific instrument systems.
Technical Method Nucleic Acid Amplification Reagents
Target Area Systemic, Whole blood, sputum,
Review Panel Microbiology
Product CodeOIH
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm278680.htm] 
Third Party Review Not Third Party Eligible
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