Skip to content

PAX-8 (SP348) Rabbit Monoclonal Antibody 10272589001

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 Number07613336231395 UDI-DI Date16 Feb 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  • Withdrawn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
PAX-8 (SP348) Rabbit Monoclonal Antibody
Generic Name
Paired box protein (PAX) IVD, antibody
Model / Ref / Catalog
10272589001
Primary DI / UDI-DI
07613336231395
FDA Product Code
NJT
GMDN Term
Paired box protein (PAX) IVD, antibody
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
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

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
  • Serial Number: No
  • Manufacturing Date: No