NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET

Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set

CENTERS FOR DISEASE CONTROL AND PREVENTION

The following data is part of a De Novo classification by Centers For Disease Control And Prevention with the FDA for Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set.

Pre-market Notification Details

DeNovo IDDEN070001
Device Name:NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
ClassificationNon-variola Orthopoxvirus Real-time Pcr Primer And Probe Set
Applicant CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 Clifton Rd., N.e. Atlanta,  GA  30333
ContactHye-joo Kim
Product CodePBK  
CFR Regulation Number866.3315 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardMicrobiology
Classification AdvisoryMicrobiology
TypePost-NSE
Date Received2007-01-16
Decision Date2018-09-21
Reclassification Order:Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

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