Devices

ARCHITECT cSystem

  • Model / Serial
    All Serial Numbers--ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.
  • Product Description
    ARCHITECT c16000 Processing Module, for In Vitro Diagnostics; List Number 3L77-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
  • Manufacturer
    Abbott Laboratories, Inc
  • 1 Event

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Drive, PO Box 152020, Irving TX 75038
  • Source
    USFDA

5 devices with a similar name

Learn more about the data here

Architect cSystems
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
    Abbott
Architect cSystems (software versions 2.10, 2.11, 2.12, 2.20, 2.20DB, 2.30, 2.60
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
    Abbott
Abbott Diagnostics ReagentPhenobarbital for ARCHITECT cSystems & AEROSET System
  • Model / Serial
    39074HW00 (exp. 9/30/06), 41008HW00 (exp. 10/31/06), 42063HW00 (exp. 12/31/06)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- USA and countries of of Canada, Chile, Germany, Australia
  • Product Description
    Phenobarbital- Reagent-Clinical Chemistry--List number: 1E08-20-Abbott Diagnostics Division
  • Manufacturer
    Abbott Laboratories Inc.
ARCHITECT cSystem
  • Model / Serial
    All Serial Numbers: ARCHITECT cSystems using ARCHITECT System Software Versions: ---Software Version--List Number--Part Number-- 2.10-- 05F48-11-- 7-99077-01 2.11-- 05F48-12 --7-99077-02 2.12 --None --------7-99077-03 2.20 --05F48-13 ---7-201738-01 2.20DB --05F48-14 ---7-201738-02 2.30-- None --202246-01 2.60-- 05F48-17-- 7-203715-01 3.00-- 05F48-15-- 7-202246-01 3.10-- 05F48-18-- 7-203715-02
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA (including Puerto Rico), Argentina, Australia, Bahamas, Bermuda, Brazil, Cayman Islands, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Hong Kong, Jamaica, Mexico, New Zealand, Panama, Singapore, Thailand, Trinidad and Tobago, Uruguay, and Venezuela.
  • Product Description
    ARCHITECT c8000 Processing Module, for In Vitro Diagnostics; List Number 106-01; Affected software: v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30, v2.60, v3.00 and v3.10; Distributed by Abbott Laboratories, Irving, TX.
  • Manufacturer
    Abbott Laboratories, Inc
Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSyste...
  • Model / Serial
    Acetaminophen (Paracetamol) Reagent (used with L3K Assay in conjunction with the Architect cSystem Analyser). An in vitro diagnostic medical device (IVD)Sekisui List Numbers: 506-10 and 506-30Abbott List Number: 3R11-20Multiple lot numbers and expiry datesARTG Number: 224545
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division