Definition: 2009 H1N1 Influenza Virus Detection And Identification Reagents Are Used To Directly Detect And Differentiate The 2009 H1N1 Influenza Virus In Human Respiratory Specimens
| Device Type ID | 3536 |
| Device Name | 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Physical State | Reagent Kit |
| Technical Method | Nucleic Acid Amplification Or Antigen Detection Assays |
| Target Area | The Device Is An In-vitro Diagnostic Device; None Of The Body Parts Will Utilize The Device Or Are Intended To Be Affected By The Device |
| Regulation Description | Reagents For Detection Of Specific Novel Influenza A Viruses. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3332 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |