Blood Glucose Test Strips
GLUCOCARD® EXPRESSION Blood Glucose Test Strips - 570050
Device Description
A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
Environmental Conditions
- 86.00
- 41.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CGA
Device Name: Glucose Oxidase, Glucose
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: Y
Medical Specialty: CH
Device IdentifiersDevice Id: 10015482570054
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00015482570057
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case Pack
Device Id: 00015482570057
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: 20015482570051
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10015482570054
Package Quantity: 216
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Master Shipper
Device Id: 50015482570052
Device Type: Unit of Use
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