D3 Fastpoint 01-123504
D3 Fastpoint 01-123504 is a multiple-genus respiratory virus antigen IVD (FDA Class I) made by Diagnostic Hybrids, Inc., cleared under FDA 510(k) K093415 on 23 Dec 2009 (1 earlier submission) and listed in FDA GUDID since 7 Mar 2019 (UDI-DI 30014613330875), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30014613330875 | Date7 Mar 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093415 | Date23 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 30014613330875
- FDA 510(k) database K093415
- FDA 510(k) database K091171
Across registries
- FDA 510(k) K093415 decided 23 Dec 2009 Active
- FDA GUDID UDI-DI 30014613330875 listed 7 Mar 2019 Listed
Timeline
- Cleared FDA 510(k) K091171
- Cleared FDA 510(k) K093415
- Listed FDA GUDID 30014613330875
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- D3 Fastpoint
- Generic name
- Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
- Model / Ref / Catalog
- 01-123504
- Primary DI / UDI-DI
- 30014613330875
- FDA product code
- GNY, OMG, GQS, LKT, GNS
- GMDN term
- Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
- Device class
- Class I
- Regulation number
- 866.3020, 866.3980, 866.3400, 866.3480, 866.3330
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OMG.
- RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY by Light Diagnostics
- ADENOVIRUS GROUP-FA LABELLED PRESERUM by Flow Laboratories, Inc.
- ADENOVIRUS-GROUP FA LABELLED (8-651 RF) by Flow Laboratories, Inc.
- MURINE MONOCLONAL ANTI-ADENOVIRUS IGG by Whittaker Bioproducts, Inc.
- LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 by Millipore Corp.