FRUC (Fructosamine) Control
CAROLINA LIQUID CHEMISTRIES CORP.® FRUC CONTROL SET CC030 - CC030
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
- Opened vials are stable for 30 days when stored refrigerated at 2 to 8°C.
- Reagent is stable when stored at 2-8° C until expiration date
- 8.00
- 2.00
Device Sizes
- Total Volume: 2 Milliliter
- Kit contains 1 control 1, 1 control 2 and 1 package insert
- Total Volume: 3 Milliliter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LCP
Device Name: Assay, Glycosylated Hemoglobin
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HE
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: 864.7470
Third Party Flag: N
Medical Specialty: HE
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 IdentifiersDevice Id: 00817302022117
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