OVF · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3500
Classification
FDA Product Code
OVF
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 866.3500
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
These reagents are nucleic acid primers and probes intended for the amplification and identification of Coxiella burnetii directly from clinical specimens. The identification aids in the diagnosis of Q Fever 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 or antigens.