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510(k) Data Aggregation

K Number

Device Name

Variola virus Real-Time PCR Assay

Manufacturer

CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

Date Cleared

2017-02-06

(298 days)

Product Code

PRA

Regulation Number

866.3316

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Product Code :

PRA

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

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