Antisera, Fluorescent, Human Metapneumovirus
The Antisera, Fluorescent, Human Metapneumovirus (product code OMG) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3980 in the Microbiology specialty (MI), cleared via 510(k). It is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimens or cell culture using immunofluorescence, aiding in the diagnosis of acute respiratory infection due to hMPV, though it does not differentiate among the four recognized genetic sub-lineages. The device is not an implant or life-sustaining.
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Basic Information
- Product Code
- OMG
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 | Mar 12, 2010 | Substantially Equivalent | Millipore Corporation |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Dec 04, 2009 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | Sep 11, 2009 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Mar 06, 2009 | Substantially Equivalent | Diagnostic Hybrids, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.