OZB · Class II · 21 CFR 866.3946

FDA Product Code OZB: Dengue Nucleic Acid Amplification Assay (naat)

A Qualitative In Vitro Diagnostic Assay For The Detection Of Dengue Virus Serotypes 1, 2, 3 Or 4 In Serum Or Plasma Specimens Collected From Human Patients With Signs And Symptoms Consistent With Dengue (mild Or Severe).

1
Total
0
Cleared
73d
Avg days
2012
Since

FDA 510(k) Cleared Dengue Nucleic Acid Amplification Assay (naat) Devices (Product Code OZB)

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

About Product Code OZB - Regulatory Context