Skip to content

Assy Rgt Dspnr Card Bmk Prep Kit 304 10637455001

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 Number07613336240311 UDI-DI Date20 Mar 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  • Withdrawn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
Assy Rgt Dspnr Card Bmk Prep Kit 304
Generic Name
Assay container IVD, single-use
Model / Ref / Catalog
10637455001
Primary DI / UDI-DI
07613336240311
FDA Product Code
JRC
GMDN Term
Assay container IVD, single-use
Device Class
Class I
Regulation Number
862.2050
GUDID distribution status
In Commercial Distribution

Other devices from Ventana Medical Systems

See all devices from Ventana Medical Systems →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number

Other properties (10)

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