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Bond™ PA0014

by Leica Biosystems Newcastle, Limited

Bond™ PA0014 is a Class I device made by Leica Biosystems Newcastle, Limited, listed in FDA GUDID since 12 Mar 2021 (UDI-DI 05055331304766), 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 Number05055331304766 UDI-DI Date12 Mar 2021ListedStatusListed 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  • Withdrawn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
Primary DI / UDI-DI
05055331304766
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)