OMG — Antisera, Fluorescent, Human Metapneumovirus Class II
Classification Details
- Product Code
- OMG
- Device Class
- Class II
- Regulation Number
- 866.3980
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093815 | millipore corporation | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | March 12, 2010 |
| K093233 | diagnostic hybrids | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | December 4, 2009 |
| K091171 | diagnostic hybrids | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | September 11, 2009 |
| K090073 | diagnostic hybrids | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | March 6, 2009 |