CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
Centers for Disease Control and Prevention · Microbiology
Open FDA's page for this record- Third party flag
- N
- City
- Atlanta
- Advisory committee description
- Microbiology
- Address 1
- 1600 Clifton Rd.
- Statement or summary
- Summary
- Product code
- OZE
- Zip code
- 30329
- Applicant
- Centers for Disease Control and Prevention
- Decision date
- 2026-09-30
- Decision code
- SESE
- Country code
- US
- Advisory committee
- MI
- Contact
- Marie Kirby
- K number
- K263035
- State
- GA
- Date received
- 2026-08-31
- Review advisory committee
- MI
- Postal code
- 30329
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Device name
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel (includes Influenza A/B Typing Kit, Influenza A Subtyping Kit, Influenza A(H5) Subtyping Kit, and Influenza B Lineage Genotyping Kit)
- Harmonized identifiers (openFDA)
- Device name
- Influenza A And Influenza B Multiplex Nucleic Acid Assay
- Medical specialty description
- Microbiology
- Regulation number
- 866.3980
- Device class
- 2
- Registration number
- 3029059580, 3002773840, 3010770794, 3003795116, 1050190, 3007799234, 3008632402, 3005360469, 3006028115, 2243471, 3019946577, 3023999024, 1528450, 3038610665, 3012494290, 1221359, 9610126, 3004141078, 3013019728, 3023372670, 3003018722, 1650733
- FEI number
- 3029059580, 3002773840, 3010770794, 3003795116, 1050190, 3007799234, 3008632402, 1000122536, 3006028115, 2243471, 3019946577, 3002806559, 3023999024, 3038610665, 3002524000, 3012494290, 1221359, 3004141078, 3013019728, 3023372670, 3005670738, 3003018722