FDA.reportPublic FDA data

BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer

Primary DI
16935784410008
Brand
BioHermes A1C EZ 2.0 Glycohemoglobin Analyzer
Company
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Model
A1C EZ 2.0
Catalog number
A1C-M21
Device description
A1C EZ 2.0 Glycohemoglobin Analyzer is intended to be used for testing glycohemoglobin concentration as anaid to monitor the risk of developing diabetes and control the status of diabetes.The HbA1c analyzer is specifically designed to be used with the corresponding test strip.
Published
2022-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16935784410008PackageGS124In Commercial Distribution
06935784410001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693578441000816935784410008
06935784410001069357844100016935784410001

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-careA collection of devices including a portable, electrically-powered, semi-automated or automated instrument (meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glycated haemoglobin (HbA1c) in a whole blood clinical specimen. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
528192913
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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