OEP
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Influenza A Virus Subtype Differentiation Nucleic Acid Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Medical specialty
- Microbiology
- FDA definition
- A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL (K140851) | Centers for Disease Control and Prevention | 2014-04-25 | + Add |
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Every clearance here is in the API, with alerts when new ones post.