OMG
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Fluorescent, Human Metapneumovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Medical specialty
- Microbiology
- FDA definition
- 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.
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| Record | Firm | Date |
|---|---|---|
| LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 (K093815) | Millipore Corporation | 2010-03-12 |
| D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (K093233) | Diagnostic Hybrids, Inc. | 2009-12-04 |
| D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (K091171) | Diagnostic Hybrids, Inc. | 2009-09-11 |
| D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (K090073) | Diagnostic Hybrids, Inc. | 2009-03-06 |
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Every clearance here is in the API, with alerts when new ones post.