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Dispette® FH1600

by Guest Scientific AG

Listed FDA GUDID listing, not in commercial distribution

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 Number07612964013304 UDI-DI Date7 Nov 2019ListedStatusListed GUDID: not 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  • Withdrawn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
Dispette®
Generic Name
Erythrocyte sedimentation rate (ESR) IVD, kit
Model / Ref / Catalog
FH1600
Primary DI / UDI-DI
07612964013304
FDA Product Code
JPH
GMDN Term
Erythrocyte sedimentation rate (ESR) IVD, kit
Device Class
Class I
Regulation Number
864.6700
GUDID distribution status
Not in Commercial Distribution

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No