Skip to content

Bond™ PA0014-U

by Leica Biosystems Newcastle, Limited

Bond™ PA0014-U is a Class I device made by Leica Biosystems Newcastle, Limited, listed in FDA GUDID since 16 Dec 2022 (UDI-DI 05055331334114), 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 Number05055331334114 UDI-DI Date16 Dec 2022ListedStatusListed 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  • Withdrawn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
Human chorionic gonadotropin beta-subunit IVD, antibody
Model / Ref / Catalog
PA0014-U
Primary DI / UDI-DI
05055331334114
FDA product code
NJT
GMDN term
Human chorionic gonadotropin beta-subunit IVD, antibody
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human chorionic gonadotropin beta-subunit IVD, antibody

Similar devices

Other devices filed under FDA product code NJT (Immunohistochemistry Reagents And Kits).

Other devices from Leica Biosystems Newcastle, Limited

See all devices from Leica Biosystems Newcastle, Limited →

Properties

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