The following data is part of a premarket notification filed by Centers For Disease Control And Prevention with the FDA for Cdc Human Influenza Virus Real-time Rt-pcr Diagnostic Panel, Influenza A/b Typing Kit, Cdc Human Influenza Virus Real-time Rt-pcr Diagnostic Panel, Influenza A Subtyping Kit, Cdc Human Influenza Virus Real-time Rt-pcr, Influenza B Lineage Genotyping .
| Device ID | K190302 |
| 510k Number | K190302 |
| Device Name: | CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping |
| Classification | Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant | Centers For Disease Control And Prevention 1600 Clifton Rd; MS VI 8-4 Atlanta, GA 30329 |
| Contact | Yon Yu |
| Correspondent | Yon Yu Centers For Disease Control And Prevention 1600 Clifton Rd; MS VI 8-4 Atlanta, GA 30329 |
| Product Code | OZE |
| Subsequent Product Code | NSU |
| Subsequent Product Code | NXD |
| Subsequent Product Code | OEP |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OQW |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-12 |
| Decision Date | 2019-03-27 |