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Architect 6L23-01

by Abbott

Architect 6L23-01 (06L2301) is a Class II device made by Abbott, approved under FDA PMA P060035 on 6 Nov 2007 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 00380740011130), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

PMA P060035

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00380740011130 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMA from GUDID NumberP060035 Date6 Nov 2007IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P060035 decided 6 Nov 2007 Active
  • FDA GUDID UDI-DI 00380740011130 listed 18 Nov 2014 Listed

Timeline

2 dated events

  1. Approved FDA PMA P060035
  2. Listed FDA GUDID 00380740011130

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
Architect
Generic name
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
Model / Ref / Catalog
6L23-01, 06L2301
Primary DI / UDI-DI
00380740011130
PMA number
FDA product code
LOM
GMDN term
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator
Device class
Class II
Regulation number
866.3172
GUDID distribution status
In Commercial Distribution

Related devices

Category: Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, calibrator

Cleared under the same submission (P060035)

and 1 more cleared under P060035

Other devices from Abbott

See all devices from Abbott →

Properties

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