- Physicians Office Resource

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

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.