QFO · Class II · 21 CFR 866.3935

FDA Product Code QFO: Zika Virus Serological Reagents

Zika Virus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Diagnosis Of Zika Virus Infection In Human Clinical Specimens From Individuals That Have Signs And Symptoms Consistent With Zika Virus Infection And/or Epidemiological Risk Factors. The Device Aids In The Presumptive Clinical Diagnosis Of Zika Virus Infection In Conjunction With Other Clinical And Laboratory Findings.

4
Total
3
Cleared
91d
Avg days
2019
Since

FDA 510(k) Cleared Zika Virus Serological Reagents Devices (Product Code QFO)

4 devices
1–4 of 4
No devices found for this product code.

About Product Code QFO - Regulatory Context