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K Number
DEN070001

Validate with FDA (Live)

Device Name
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET
Manufacturer
CENTERS FOR DISEASE CONTROL AND PREVENTION
Date Cleared
2018-09-21

(4266 days)

Product Code
PBK
Regulation Number
866.3315
Type
Post-NSE
Panel
Microbiology
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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