Architect 6L22-10

Architect 6L22-10 (06L2210) is a Class II device made by Abbott, approved under FDA PMA P080023 on 10 Apr 2009 and listed in FDA GUDID since 30 Jan 2015 (UDI-DI 00380740011116), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00380740011116 UDI-DI	Date30 Jan 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA PMAAPRL from GUDID	NumberP080023	Date10 Apr 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00380740011116
FDA PMA database PMA number P080023

Across registries

2 registries list this device

FDA PMA P080023 decided 10 Apr 2009 Active
FDA GUDID UDI-DI 00380740011116 listed 30 Jan 2015 Listed

Timeline

2 dated events

10 Apr 2009 Approved FDA PMA P080023
30 Jan 2015 Listed FDA GUDID 00380740011116

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name: Architect
Generic name: Hepatitis B virus core total antibody IVD, control
Model / Ref / Catalog: 6L22-10, 06L2210

Primary DI / UDI-DI: 00380740011116
PMA number: P080023
FDA product code: LOM
GMDN term: Hepatitis B virus core total antibody IVD, control

Device class: Class II
Regulation number: 866.3172
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (11, all answered No)