Skip to content

Gram Stain Core Kit 10608358001

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 Number07613336239544 UDI-DI Date10 Apr 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  • Withdrawn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
Gram Stain Core Kit
Generic Name
Cytokeratin IVD, antibody
Model / Ref / Catalog
10608358001
Primary DI / UDI-DI
07613336239544
FDA Product Code
HYI
GMDN Term
Cytokeratin IVD, antibody
Device Class
Class I
Regulation Number
864.1850
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