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DHI Specimen Collection System 404C

by Diagnostic Hybrids, Inc.

DHI Specimen Collection System 404C is a Class I device made by Diagnostic Hybrids, Inc., listed in FDA GUDID since 28 Nov 2018 (UDI-DI 30014613337294), 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 Number30014613337294 UDI-DI Date28 Nov 2018ListedStatusListed 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  • Withdrawn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
DHI Specimen Collection System
Generic name
Oral/upper respiratory tract specimen collection kit IVD, clinical
Model / Ref / Catalog
404C
Primary DI / UDI-DI
30014613337294
FDA product code
KXG
GMDN term
Oral/upper respiratory tract specimen collection kit IVD, clinical
Device class
Class I
Regulation number
880.6025
GUDID distribution status
In Commercial Distribution

Related devices

Category: Oral/upper respiratory tract specimen collection kit IVD, clinical

Similar devices

Other devices filed under FDA product code KXG (APPLICATOR, ABSORBENT TIPPED, STERILE).

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)