Antisera, Fluorescent, Human Metapneumovirus
Microbiology · 21 CFR 866.3980
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Millipore CorporationMar 12, 2010
K093815 · LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124
- Diagnostic Hybrids, Inc.Dec 4, 2009
K093233 · D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
- Diagnostic Hybrids, Inc.Sep 11, 2009
K091171 · D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
- Diagnostic Hybrids, Inc.Mar 6, 2009
K090073 · D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT