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335816

by Becton, Dickinson and Company

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 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382903358168 UDI-DI Date18 Dec 2018ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
CD79b cell marker IVD, antibody
Model / Ref / Catalog
335816
Primary DI / UDI-DI
00382903358168
FDA product code
MVU
GMDN term
CD79b cell marker IVD, antibody
Device class
Class I
Regulation number
864.4020
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (11)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No