CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT— 510(k) K133869
Substantially EquivalentCenter For Disease Control and Prevention (Cdc)
FDA 510(k) clearance K133869 for CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT, Substantially Equivalent on 2014-01-17. Applicant: Center For Disease Control and Prevention (Cdc). Device class: 2.
Clearance details
- Applicant
- Center For Disease Control and Prevention (Cdc)
- Product code
- Code OZE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
Recent devices under product code OZE
view all- K243274 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) +3 more
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- K241110 — CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
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- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
Data sourced from openFDA. This site is unofficial and independent of the FDA.