Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124
FDA 510(k) K093815 · Millipore Corporation
Submission
- Device name
- Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124
- Applicant
- Millipore Corporation
Temecula, CA, US - Received
- December 14, 2009
- Decision date
- March 12, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMG – Antisera, Fluorescent, Human Metapneumovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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.
Other 510(k)s with product code OMG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093233 | D3 Fastpoint L-Dfa Rsv/Mvp Identification KitOMG · Traditional | Diagnostic Hybrids, Inc. | 12/04/2009SE |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification KitOMG · Traditional | Diagnostic Hybrids, Inc. | 09/11/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | Diagnostic Hybrids, Inc. | 03/06/2009SE |
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Questions and answers
When was Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124 cleared by the FDA?
Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124 (K093815) received a 510(k) decision of Substantially Equivalent on March 12, 2010, 88 days after the submission was received.
What is the product code of K093815?
The FDA product code is OMG – Antisera, Fluorescent, Human Metapneumovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3980.