Reagent intended for use as human hemoglobin standard for the cyanmethemoglobin hemoglobin procedure 1 x 2.0ml

Reagent intended for use as human hemoglobin standard for the cyanmethemoglobin hemoglobin procedure 1 x 2.0ml
Pointe Scientific, Inc. - H7506-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: KHG

Device Name: Whole Blood Hemoglobin Determination

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: 864.7500

Third Party Flag: Y

Medical Specialty: HE

Device Id: 00811727011480

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