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Diagnostic BioSystems K094-100-HL

by Diagnostic BioSystems

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846405017362 UDI-DIDate5 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Diagnostic BioSystems
Generic Name
Wash/cleaning solution IVD, automated/semi-automated system
Model / Reference
K094-100-HL
Primary DI / UDI-DI
00846405017362
FDA Product Code
PPM
GMDN Term
Wash/cleaning solution IVD, automated/semi-automated system
Device Class
Class I
Regulation Number
864.4010
GUDID distribution status
In Commercial Distribution

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

  • Single Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No