Skip to content

Architect 7K61-12

by Abbott Ireland

Architect 7K61-12 (07K6112) is a Class II device made by Abbott Ireland, listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740014155), 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 Number00380740014155 UDI-DI Date9 Sep 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  • Withdrawn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
Architect
Generic name
Vitamin B12 IVD, control
Model / Ref / Catalog
7K61-12, 07K6112
Primary DI / UDI-DI
00380740014155
FDA product code
JIT, JJX, CDD
GMDN term
Vitamin B12 IVD, control
Device class
Class II
Regulation number
862.1150, 862.1660, 862.1810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Vitamin B12 IVD, control

Similar devices

Other devices filed under FDA product code JIT (CALIBRATOR, SECONDARY).

Other devices from Abbott Ireland

See all devices from Abbott Ireland →

Properties

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