- Physicians Office Resource

CREATININE CARTRIDGE
i-STAT - 03P84-25

Device Description

An electrochemical sensor in which an interaction between one or more immobilized enzymes (e.g., creatinine iminohydrolase) and creatinine occurs, developing an electrical potential or current proportional to the quantity of ammonium (NH4+) resulting from the reaction. The electrode may use one of several technologies (e.g., enzyme immobilized by adsorption) and mechanisms (e.g., diffusion of ammonium). It is used to measure creatinine in body fluids (e.g., urine).

Environmental Conditions

Handling Environment Temperature - Degrees Celsius

8.00
2.00

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: CGL

Device Name: Electrode, Ion Based, Enzymatic, Creatinine

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: 862.1225

Third Party Flag: Y

Medical Specialty: CH

Device Identifiers

Device Id: 10054749000125

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

Device Id: 00054749000128

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10054749000125

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

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