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D3 01-002015

by Diagnostic Hybrids, Inc.

D3 01-002015 is a Class I device made by Diagnostic Hybrids, Inc., listed in FDA GUDID since 31 Jan 2019 (UDI-DI 30014613330271), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613330271 UDI-DI Date31 Jan 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
D3
Generic name
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Model / Ref / Catalog
01-002015
Primary DI / UDI-DI
30014613330271
FDA product code
KIP
GMDN term
Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay
Device class
Class I
Regulation number
864.2875
GUDID distribution status
In Commercial Distribution

Related devices

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

Similar devices

Other devices filed under FDA product code KIP (FORMULATIONS, BALANCED SALT SOLUTIONS).

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)