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McKesson 5012

by Mckesson Medical-Surgical Inc.

McKesson 5012 is a Class II device made by Mckesson Medical-Surgical Inc., listed in FDA GUDID since 9 Dec 2016 (UDI-DI 20612479202775), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20612479202775 UDI-DI Date9 Dec 2016ListedStatusListed 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  • Withdrawn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
McKesson
Generic name
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Model / reference
5012
Primary DI / UDI-DI
20612479202775
FDA product code
KTN
GMDN term
Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
866.5640
GUDID distribution status
In Commercial Distribution

Related devices

Category: Epstein-Barr virus (EBV) heterophile antibody IVD, kit, rapid ICT, clinical

Similar devices

Other devices filed under FDA product code KTN (System, Test, Infectious Mononucleosis).

Other devices from Mckesson Medical-Surgical Inc.

See all devices from Mckesson Medical-Surgical Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)