D3 Ultra Duet Dfa Respiratory Virus Identification Kit
FDA 510(k) K091171 · Diagnostic Hybrids, Inc.
Submission
- Device name
- D3 Ultra Duet Dfa Respiratory Virus Identification Kit
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- April 22, 2009
- Decision date
- September 11, 2009
- 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 |
|---|---|---|---|
| K093815 | Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124OMG · Traditional | Millipore Corporation | 03/12/2010SE |
| K093233 | D3 Fastpoint L-Dfa Rsv/Mvp Identification KitOMG · Traditional | Diagnostic Hybrids, Inc. | 12/04/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | Diagnostic Hybrids, Inc. | 03/06/2009SE |
More from Diagnostic Hybrids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | 05/18/2010SE |
| K093415 | D3 Fastpoint L-Dfa Parainfluenza Virus/Adenovirus Identification KitGQS · Traditional | 12/23/2009SE |
| K093233 | D3 Fastpoint L-Dfa Rsv/Mvp Identification KitOMG · Traditional | 12/04/2009SE |
| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | 10/21/2009SE |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | 08/28/2009SE |
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | 08/28/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | 05/21/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | 03/06/2009SE |
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | 12/23/2008SE |
| K081746 | D3 Duet Dfa Influenza A/Respiratory Virus Screening KitGNW · Traditional | 12/23/2008SE |
Questions and answers
When was D3 Ultra Duet Dfa Respiratory Virus Identification Kit cleared by the FDA?
D3 Ultra Duet Dfa Respiratory Virus Identification Kit (K091171) received a 510(k) decision of Substantially Equivalent on September 11, 2009, 142 days after the submission was received.
What is the product code of K091171?
The FDA product code is OMG – Antisera, Fluorescent, Human Metapneumovirus, a Class II (moderate risk) device regulated under 21 CFR 866.3980.