Assay, Direct, Nucleic Acid Amplification, Influenza Virus
Device Code: 3509
Product Code(s):
NIA Definition: These Reagents Are Nucleic Acid Primers And Probes For The Amplification And Identification Of Influenza Virus Directly From Clinical Specimens. The Identification Aids In The Diagnosis Of Influenza And Provides Epidemiological Information On This Di
Device Classification Information
| Device Type ID | 3509 |
| Device Name | Assay, Direct, Nucleic Acid Amplification, Influenza Virus |
| Regulation Description | Influenza Virus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3330 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NIA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3509 |
| Device | Assay, Direct, Nucleic Acid Amplification, Influenza Virus |
| Product Code | NIA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Influenza Virus Serological Reagents. |
| CFR Regulation Number | 866.3330 [🔎] |
TPLC Last Update: 2019-04-02 20:31:25