ACE Axcel® 404200-1

GUDID 00857969006709

ACE Axcel Clinical Chemistry System with ISE

ALFA WASSERMANN, INC.

Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

• Primary Device ID: 00857969006709
• NIH Device Record Key: 47e0b5a8-b370-4375-901e-ee0c6c983abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACE Axcel®
• Version Model Number: 404200-1
• Catalog Number: 404200-1
• Company DUNS: 781990924
• Company Name: ALFA WASSERMANN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com
• Phone: 973-852-0178
• Email: AGennis@alfawassermannus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857969006709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113253

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-15
• Device Publish Date: 2021-01-07

Devices Manufactured by ALFA WASSERMANN, INC.

• 00857969006693 - ACE Alera®: 2021-01-15 ACE Alera Clinical Chemistry System with ISE
• 00857969006709 - ACE Axcel®: 2021-01-15ACE Axcel Clinical Chemistry System with ISE
• 00857969006709 - ACE Axcel®: 2021-01-15 ACE Axcel Clinical Chemistry System with ISE
• 00857969006662 - ACE: 2020-07-09 ALT Reagent
• 00857969006679 - ACE: 2020-07-09 AST Reagent
• 00857969006686 - ACE: 2020-07-09 AST Reagent
• 00857969006624 - ACE: 2020-04-17 NORMAL SALINE DILUENT
• 00857969006631 - ACE: 2020-04-17 SYSTEM DILUENT
• 00857969006648 - ACE: 2020-04-17 ISE WASH