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Architect 6C07-10

by Abbott Ireland Diagnostics

Architect 6C07-10 (06C0710) is a Class III device made by Abbott Ireland Diagnostics, listed in FDA GUDID since 18 Nov 2014 (UDI-DI 00380740009014), 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 Number00380740009014 UDI-DI Date18 Nov 2014ListedStatusListed 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  • Withdrawn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
Free (unbound) prostate specific antigen (fPSA) IVD, control
Model / Ref / Catalog
6C07-10, 06C0710
Primary DI / UDI-DI
00380740009014
FDA product code
MTG
GMDN term
Free (unbound) prostate specific antigen (fPSA) IVD, control
Device class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Free (unbound) prostate specific antigen (fPSA) IVD, control

Similar devices

Other devices filed under FDA product code MTG (TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CANCER FROM BENIGN CONDITIONS).

Other devices from Abbott Ireland Diagnostics

See all devices from Abbott Ireland Diagnostics →

Properties

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