Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer

Li+ Sensor module, an in vitro diagnostics device to be used on the RAPIDChem® 754 analyzer
Sensor Module, Li+ - 10318482

A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CEM

Device Name: Electrode, Ion Specific, Potassium

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1600

Third Party Flag: Y

Medical Specialty: CH

Code: JGS

Device Name: Electrode, Ion Specific, Sodium

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1665

Third Party Flag: Y

Medical Specialty: CH

Code: CGZ

Device Name: Electrode, Ion-Specific, Chloride

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 862.1170

Third Party Flag: Y

Medical Specialty: CH

Device Id: 00630414484563

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