FDA.reportPublic FDA data

BioHermes Glycohemoglobin Analytical Column

Primary DI
06935784430146
Brand
BioHermes Glycohemoglobin Analytical Column
Company
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Model
BH-CC14
Catalog number
HP-Z114
Device description
Glycohemoglobin Analytical Column 1 pcs/kit (3000 tests)The Glycohemoglobin Analytical Column is intended to be used with the BH60 Automated Glycohemoglobin Analyzer, which is based on the principle of ion-exchange high-performance liquid chromatography (HPLC), to separate glycohemoglobin (HbA1c) from human whole blood.
Published
2022-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935784430146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935784430146069357844301466935784430146

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser column IVDA component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various chemical and physical properties and their interaction with a specific column filling. The internal diameter of the HPLC tubing (typically ranges from under 0.3 mm to greater than 10 mm) determines the quantity of analyte that can be loaded and analyser sensitivity. The tubes are made of various materials including stainless steel and fused silica.

Regulatory Flags#

DUNS number
528192913
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935784411077BioHermes A1cChek Express Glycohemoglobin AnalyzerA1C-EXP M12A1C-M422021-05-25
06935784450106BioHermes Blood Glucose Control SolutionGLU-GE C01GLU-C122024-01-10
06935784400057BioHermes GluCoA1c Blood Glucose Test StripsGLU-A1C S04GLU-S222021-05-25
06935784420055BioHermes GluCoA1c Blood Glucose Test StripsGLU-A1C S06GLU-S322021-05-25
06935784450076BioHermes Limpid Blood Glucose Test StripsGM S01GLU-S422021-05-25
06935784410001BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer A1C EZ 2.0A1C-M212022-08-26
06935784420253BioHermes GluCoA1c Blood Glucose and Glycohemoglobin AnalyzerGLU-A1C M14GCA-M312022-08-26
06935784420260BioHermes GluCoA1c Blood Glucose and Glycohemoglobin AnalyzerGLU-A1C M24GCA-M412022-08-26
06935784400088BioHermes Glycohemoglobin Quality ControlA1C-GE C01A1C-C122022-08-26
16935784410008BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer A1C EZ 2.0A1C-M212022-08-26
16935784420250BioHermes GluCoA1c Blood Glucose and Glycohemoglobin AnalyzerGLU-A1C M14GCA-M312022-08-26
16935784420267BioHermes GluCoA1c Blood Glucose and Glycohemoglobin AnalyzerGLU-A1C M24GCA-M412022-08-26
06935784400019BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer A1C EZ 2.0A1C-M212021-05-25
06935784420062BioHermes Glycohemoglobin Quality ControlA1C-GE C01A1C-C122021-05-25
06935784430115BioHermes Glycohemoglobin Analytical ColumnBH-CC11HP-Z1112022-01-05
06935784430122BioHermes Glycohemoglobin Analytical ColumnBH-CC12HP-Z1122022-01-05
06935784430139BioHermes Glycohemoglobin Analytical ColumnBH-CC13HP-Z1132022-01-05
06935784430214BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode)BH-L01HP-L1212022-01-05
06935784430221BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode)BH-L01HP-L1222022-01-05
06935784430238BioHermes Glycohemoglobin Reagent Kit (HPLC, Standard Mode)BH-L01HP-L1232022-01-05