GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.)

GLUCOCARD Expression Level 2 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570071 is used as the assigned UDI for the Class I device.)
GLUCOCARD® Expression™ Level 2 Control Solution - 570007

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NBW

Device Name: System, Test, Blood Glucose, Over The Counter

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: 862.1345

Third Party Flag: N

Medical Specialty: CH

Device Id: 00015482570071

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