Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus
NHZ is the FDA product code for Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus, a class I device type, regulated under 21 CFR 866.3400. FDA's definition for this code reads: "These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- NHZ
- Device name
- Assay, Direct, Nucleic Acid Amplification, Parainfluenza Virus
- FDA definition
- These reagents are nucleic acid primers and probes for the amplification and identification of Parainfluenza virus directly from clinical specimens. The identification aids in the diagnosis of influenza and provides epidemiological information on this disease. This reagent differs from the description in the regulation in that it consists of nucleic acid primers and probes rather than antisera.
- Regulation
- 21 CFR 866.3400
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code NHZ.
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