FDA.reportPublic FDA data

BioHermes Glycohemoglobin Quality Control

Primary DI
06935784400088
Brand
BioHermes Glycohemoglobin Quality Control
Company
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Model
A1C-GE C01
Catalog number
A1C-C12
Device description
Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (glycohemoglobin analyzers and test kits) with the methodology of boronate affinity chromatography, manufactured by Wuxi BioHermes Bio & Medical Technology Co.,Ltd.. Contents: Level 1: 5 vials x 50uL; Level 2: 5 vials x 50uL; Package Insert×1.
Published
2022-08-26
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
06935784400088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935784400088069357844000886935784400088

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528192913
Device count
1
Kit
true
Lot or batch
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
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
06935784430146BioHermes Glycohemoglobin Analytical ColumnBH-CC14HP-Z1142022-01-05
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