This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems.

This product is intended for in vitro diagnostic use in the quality control of the Randox Liquid Fructosamine assay on clinical chemistry systems.
FRUC CONTROL 3 - FR2996

Device Description

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

Environmental Conditions

Special Storage Condition, Specify

Once reconstituted the components of the serum are stable for 28 days at +2oC to +8oC, and 1 month at –20oC when frozen once.

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: JJX

Device Name: Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 862.1660

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 05055273203134

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