NHY · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3480
Classification
FDA Product Code
NHY
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.3480
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
These reagents are nucleic acid primers and probes for the amplification and identification of Respiratory Syncytial 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.