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Amplification Kit 05266114001

by Ventana Medical Systems

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 Number04015630971299 UDI-DI Date15 Dec 2025ListedStatusListed 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  • Withdrawn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
Amplification Kit
Generic Name
Immunohistochemistry signal amplification reagent IVD
Model / Ref / Catalog
05266114001
Primary DI / UDI-DI
04015630971299
FDA Product Code
NJT
GMDN Term
Immunohistochemistry signal amplification reagent IVD
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

Other devices from Ventana Medical Systems

See all devices from Ventana Medical Systems →

Properties

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

Other properties (9)

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