VARIANT II TURBO Hemoglobin Testing System WITHOUT Computer
VARIANT II TURBO - 270-2601
Device Description
A mains electricity (AC-powered) laboratory instrument intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c), also known as glycohaemoglobin, glycosylated haemoglobin or glucosylated haemoglobin, in a clinical specimen. It typically uses a separation technique that is based on charge differences (i.e., ion-exchange chromatography, high pressure liquid chromatography, electrophoresis), chemical analysis (i.e., colorimetry, spectrophotometry), or structural differences (i.e., affinity chromatography and immunoassay).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LDM
Device Name: Instrumentation, High Pressure Liquid Chromatography
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: TX
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: 862.2260
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00847817015786
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