HbA1c (Hemoglobin A1c) calibrator

HbA1c (Hemoglobin A1c) calibrator
CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL - 7-H7541-CAL

Device Description

A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug voriconazole in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

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

Special Storage Condition, Specify

Protect from light and heat. Do not freeze. Reconstituted calibrator sets are stable for 30 days if stored at 2 to 8° C

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

Total Volume: 0.5 Milliliter

Kit contains 1 cal 1, 1 cal 2, 1 cal 3, 1 cal 4 and 1 package insert

Total Volume: 0.5 Milliliter
Kit contains 1 cal 1, 1 cal 2, 1 cal 3, 1 cal 4 and 1 package insert

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

Device Identifiers

Device Id: 00817302022179

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