Variola virus Real-Time PCR Assay— 510(k) DEN160016
UnknownCenters For Disease Control and Prevention (CDC)
FDA 510(k) clearance DEN160016 for Variola virus Real-Time PCR Assay, Unknown on 2017-02-06. Applicant: Centers For Disease Control and Prevention (CDC). Device class: 2.
Clearance details
- Applicant
- Centers For Disease Control and Prevention (CDC)
- Product code
- Code PRA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3316
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Atlanta, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.