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Architect 06R8601

by Abbott Laboratories

Architect 06R8601 is a device classified as Not classified made by Abbott Laboratories, listed in FDA GUDID since 19 May 2020 (UDI-DI 00380740191818), 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 Number00380740191818 UDI-DI Date19 May 2020ListedStatusListed 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  • Withdrawn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
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Model / Ref / Catalog
06R8601
Primary DI / UDI-DI
00380740191818
FDA product code
QKO
GMDN term
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator
Device class
N
GUDID distribution status
In Commercial Distribution

Related devices

Category: SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibrator

Similar devices

Other devices filed under FDA product code QKO (Reagent, coronavirus serological).

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

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