ACE Alera Clinical Chemistry System with ISE

ACE Alera Clinical Chemistry System with ISE
ACE Alera® - 402900-1

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 Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JJE

Device Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.2160

Third Party Flag: N

Medical Specialty: CH

Device Id: 00857969006693

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A