D3 Fastpoint 01-123104

by Diagnostic Hybrids, Inc.

D3 Fastpoint 01-123104 is a Class I device made by Diagnostic Hybrids, Inc., cleared under FDA 510(k) K091171 on 11 Sep 2009 and listed in FDA GUDID since 7 Mar 2019 (UDI-DI 30014613330851), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number30014613330851 UDI-DI	Date7 Mar 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK091171	Date11 Sep 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 30014613330851
FDA 510(k) database 510(k) number K091171

Across registries

2 registries list this device

FDA 510(k) K091171 decided 11 Sep 2009 Active
FDA GUDID UDI-DI 30014613330851 listed 7 Mar 2019 Listed

Timeline

2 dated events

11 Sep 2009 Cleared FDA 510(k) K091171
7 Mar 2019 Listed FDA GUDID 30014613330851

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: D3 Fastpoint
Generic name: Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog: 01-123104

Primary DI / UDI-DI: 30014613330851
510(k) Number: K091171
FDA product code: LKT, GNY, GQS, GNS, OMG
GMDN term: Influenza A/B virus antigen IVD, kit, fluorescent immunoassay

Device class: Class I
Regulation number: 866.3480, 866.3020, 866.3400, 866.3330, 866.3980
GUDID distribution status: In Commercial Distribution

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

Single use
Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (10, all answered No)