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D3 Fastpoint 01-123304

by Diagnostic Hybrids, Inc.

D3 Fastpoint 01-123304 is a multiple-genus respiratory virus antigen IVD (FDA Class I) 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 30014613330868), 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

510(k) K091171

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613330868 UDI-DI Date7 Mar 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091171 Date11 Sep 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091171 decided 11 Sep 2009 Active
  • FDA GUDID UDI-DI 30014613330868 listed 7 Mar 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091171
  2. Listed FDA GUDID 30014613330868

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
D3 Fastpoint
Generic name
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
01-123304
Primary DI / UDI-DI
30014613330868
510(k) Number
FDA product code
LKT, OMG, GQS, GNS, GNY
GMDN term
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Device class
Class I
Regulation number
866.3480, 866.3980, 866.3400, 866.3330, 866.3020
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Cleared under the same submission (K091171)

Similar devices

Other devices filed under FDA product code LKT (RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA).

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)