Novel Influenza A Virus, A/h5 Ns1 Protein
Device Code: 3531
Product Code(s):
OMS Definition: Novel Influenza A Virus Reagents Are Used To Directly Detect And Differentiate Novel Influenza A Virus Specific Nonstructural Protein 1 (NS1) In Human Respiratory Specimens Or Viral Cultures. Detection And Differentiation Of Specific NS1 Protein Aids
Device Classification Information
| Device Type ID | 3531 |
| Device Name | Novel Influenza A Virus, A/h5 Ns1 Protein |
| Physical State | OIVD |
| Technical Method | Immunoassay Using PDZ Domains In Intracellular Receptors To Capture Influenza A/H5 NS1 Protein |
| Target Area | PDZ Ligands (PL) Of NS1 Protein |
| 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)
|
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3332 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3531 |
| Device | Novel Influenza A Virus, A/h5 Ns1 Protein |
| Product Code | OMS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Reagents For Detection Of Specific Novel Influenza A Viruses. |
| CFR Regulation Number | 866.3332 [🔎] |
TPLC Last Update: 2019-04-02 20:31:49