This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 1 x 1.0ml

This product is for the purpose of standardizing results obtained from run to run in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 1 x 1.0ml
Pointe Scientific, Inc. - G7540-STD

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative measurement of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00811727011329

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