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Bond™ PA0449

by Leica Biosystems Newcastle, Limited

Listed FDA GUDID listing, not in commercial distribution

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055331304087 UDI-DI Date28 May 2021ListedStatusListed GUDID: not 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  • Withdrawn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
Bond™
Generic Name
Coagulation factor XIIIa pro-enzyme subunit IVD, antibody
Model / Ref / Catalog
PA0449
Primary DI / UDI-DI
05055331304087
FDA Product Code
NJT
GMDN Term
Coagulation factor XIIIa pro-enzyme subunit IVD, antibody
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
Not in Commercial Distribution

Other devices from Leica Biosystems Newcastle, Limited

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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