OMG · Class II · 21 CFR 866.3980

FDA Product Code OMG: Antisera, Fluorescent, Human Metapneumovirus

It Is Intended For The Qualitative Detection And Identification Of Human Metapneumovirus (hmpv) In Direct Respiratory Specimens Or Cell Culture. The Assay Detects Hmpv Antigens By Immunofluorescence Using Antibodies, From Patients With Signs And Symptoms Of Acute Respiratory Infection. This Assay Detects But Is Not Intended To Differentiate The Four Recognized Genetic Sub-lineages Of Hmpv.

4
Total
4
Cleared
84d
Avg days
2009
Since

FDA 510(k) Cleared Antisera, Fluorescent, Human Metapneumovirus Devices (Product Code OMG)

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

About Product Code OMG - Regulatory Context