OUC · Class II · 21 CFR 866.3395

FDA Product Code OUC: Norovirus Serological Reagent

Norovirus Serological Reagents Are Devices That Consist Of Antigens And Antisera For The Detection Of Anti-norovirus Antibodies Or Norovirus Antigens. The Detection Aids In The Clinical Laboratory Diagnosis Of Norovirus Infection In Individuals With Signs And/or Symptoms Of Acute Gastroenteritis, Or In The Determining The Etiology Of Acute Gastroenteritis Outbreaks.

1
Total
0
Cleared
7d
Avg days
2011
Since

FDA 510(k) Cleared Norovirus Serological Reagent Devices (Product Code OUC)

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

About Product Code OUC - Regulatory Context