QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY— 510(k) DEN140004

Name: FDA 510(k) clearance DEN140004
Creator: U.S. Food and Drug Administration
Published: 2014-05-13

Unknown

Diagnostic Hybrids, Inc.

FDA 510(k) clearance DEN140004 for QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY, Unknown on 2014-05-13. Applicant: Diagnostic Hybrids, Inc.. Device class: 2.

Clearance details

Applicant: Diagnostic Hybrids, Inc.
Product code: Code PGI
Device class: Class 2
Regulation: 21 CFR 866.3309
Advisory panel: Microbiology
Date received: 2014-02-21
Decision date: 2014-05-13
Decision: Unknown
Clearance type: Post-NSE
Location: Athens, OH, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.