OVF · Class I · 21 CFR 866.3500

FDA Product Code OVF: Assay, Direct, Nucleic Acid Amplification, Q Fever

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.

1
Total
1
Cleared
200d
Avg days
2011
Since

FDA 510(k) Cleared Assay, Direct, Nucleic Acid Amplification, Q Fever Devices (Product Code OVF)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OVF - Regulatory Context