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Bond PA0122-U

by Leica Biosystems Newcastle, Limited

Bond PA0122-U is a CD3 cell marker IVD (FDA Class I; FDA product code NJT, Immunohistochemistry Reagents And Kits) made by Leica Biosystems Newcastle, Limited, listed in FDA GUDID since 28 Jul 2023 (UDI-DI 05055331334435), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055331334435 UDI-DI Date28 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Bond
Generic name
CD3 cell marker IVD, antibody
Model / Ref / Catalog
PA0122-U
Primary DI / UDI-DI
05055331334435
FDA product code
NJT
GMDN term
CD3 cell marker IVD, antibody
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: CD3 cell marker IVD, antibody

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Other devices filed under CD3 cell marker IVD, antibody.

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)