A glucose test system is a device intended for the quantitative in vitro determination of Glucose concentration in serum, plasma and urine
GLUC-PAP - GL1021
Device Description
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.
Environmental Conditions
- The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.
- 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: 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 Identifiers
Device Id: 05055273203165
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
