ACE Alera®

Basic Information

• Brand Name: ACE Alera®
• Primary DI: 00857969006693
• Version / Model: 402900-1
• Catalog Number: 402900-1
• Company Name: ALFA WASSERMANN, INC.
• Labeler DUNS: 781990924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-07
• Public Version: 1
• Public Version Date: 2021-01-15
• Public Version Status: New
• Public Device Record Key: 8ba14d9a-efa8-4d1a-b81a-0f3a56f88149

Device Description

ACE Alera Clinical Chemistry System with ISE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56680	Multichannel clinical chemistry analyser IVD, point-of-care, line-powered	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, metabolites, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents and incorporates multiple channels using more two or more technologies which may include microfluidics, enzymatic chemistry, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857969006693	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123018	000