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.
Leading manufacturers include Diagnostic Hybrids, Inc..
4
Total
4
Cleared
84d
Avg days
2009
Since
FDA 510(k) Cleared Antisera, Fluorescent, Human Metapneumovirus Devices (Product Code OMG)
4 devices
Cleared
Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
Diagnostic Hybrids, Inc.
Microbiology
51d
Cleared
Sep 11, 2009
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
Diagnostic Hybrids, Inc.
Microbiology
142d
Cleared
Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
Diagnostic Hybrids, Inc.
Microbiology
53d