ISE (Electrolytes) Reference - CX3 Reagent 1 x 2000 mL

ISE (Electrolytes) Reference
ISE ELECTROLYTE REFERENCE 88811 - 88811

Device Description

A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable when stored at 8-30° C until expiration date

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 30 days

Storage Environment Temperature - Degrees Celsius

30.00
8.00

Device Sizes

Kit contains 1 R1 and 1 package insert

Total Volume: 2000 Milliliter

Kit contains 1 R1 and 1 package insert
Total Volume: 2000 Milliliter

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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: 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

Code: JFP

Device Name: Electrode, Ion Specific, Calcium

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: 862.1145

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: JFL

Device Name: Ph Rate Measurement, Carbon-Dioxide

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: 862.1160

Third Party Flag: Y

Medical Specialty: CH

Device Identifiers

Device Id: 00817302020670

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