- Physicians Office Resource

FRUC (Fructosamine) w/ cal 2 x 40 tests
CAROLINA LIQUID CHEMISTRIES CORP.™ FRUC FRUCTOSAMINE CC612 - CC612

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the glycated serum protein fructosamine in a clinical specimen, using a spectrophotometry method. It is typically used to aid in monitoring of average glucose levels and glycaemic control in diabetic patients.

Environmental Conditions

Special Storage Condition, Specify

Reagent is stable on board a clinical analyzer for 15 days

Special Storage Condition, Specify

Reagent is stable when stored at 2-8° C until expiration date

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Kit contains 2 Buffer bottles, 1 calibrator bottle, 2 empty reagent cartridges, 1 package insert and 2 user defined parameters

Total Volume: 2 Milliliter

Total Volume: 11 Milliliter

Kit contains 2 Buffer bottles, 1 calibrator bottle, 2 empty reagent cartridges, 1 package insert and 2 user defined parameters
Total Volume: 2 Milliliter
Total Volume: 11 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 Identifiers

Device Id: 00817302022131

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

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