FDA.reportPublic FDA data

BioHermes Automated Glycohemoglobin Analyzer

Primary DI
06935784430016
Brand
BioHermes Automated Glycohemoglobin Analyzer
Company
Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
Model
BH60
Catalog number
HP-M51
Device description
The BH60 Automated Glycohemoglobin Analyzer is intended for in vitro diagnostic use for the quantitative measurement of HbA1c in whole blood specimens in combination with Glycohemoglobin Analytical Column and Glycohemoglobin Reagent Kit produced by Wuxi Biohermes Bio & Medical Technology Co., Ltd. using ion-exchange high-performance liquid chromatography (HPLC).
Published
2022-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PDJHemoglobin A1c Test System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PDJHemoglobin A1c Test SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06935784430016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06935784430016069357844300166935784430016

GMDN Terms#

Term, Definition table
TermDefinition
Glycated haemoglobin (HbA1C) analyser IVDA 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).

Sterilization Methods#

Method table
Method

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740208622ARCHITECTAbbott GmbHPDJ2026-05-15
00380740208639AlinityAbbott GmbHPDJ2026-05-15
04562185405262GR01 HbA1c Elution Buffer No. 1TOSOH CORPORATIONPDJ2026-01-05
04562185405279GR01 HbA1c Elution Buffer No. 2TOSOH CORPORATIONPDJ2026-01-05
04562185405286GR01 HbA1c Elution Buffer No. 3TOSOH CORPORATIONPDJ2026-01-05
04562185400571HbA1c Diluting SolutionTOSOH CORPORATIONPDJ2026-01-05
04562185404920Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01TOSOH CORPORATIONPDJ2026-01-05
0456218540493790 Sample Loader TOSOH CORPORATIONPDJ2026-01-05
04562185404944290 Sample LoaderTOSOH CORPORATIONPDJ2026-01-05
04562185405255TSKgel GR01 HbA1c ColumnTOSOH CORPORATIONPDJ2026-01-05
04562185406207Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 LATOSOH CORPORATIONPDJ2026-01-05
07613336120927Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07613336157824Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics GmbHPDJ2020-04-14
07070060014555Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2019-05-31
00380740135591AlinityAbbott GmbHPDJ2019-04-08
00630414220505Atellica CH A1c_ESiemens Healthcare Diagnostics Inc.PDJ2019-03-14
15099590012120AU BECKMAN COULTER IRELAND INC.PDJ2019-02-13
00630414006666Dimension Vista System Flex reagent cartridge A1C KITSiemens Healthcare Diagnostics Inc.PDJ2019-02-12
00630414006659Dimension Clinical Chemistry System A1C KitSiemens Healthcare Diagnostics Inc.PDJ2018-12-06
07070060012889Afinion HbA1c DxAbbott Diagnostics Technologies ASPDJ2018-11-01
00628063401147HbA1c AssaySEKISUI DIAGNOSTICS, LLCPDJ2018-09-24
00630414002859ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002866ADVIA Chemistry Enzymatic Hemoglobin A1cSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
00630414002880ADVIA Chemistry Enzymatic hemoglobin A1c PretreatmentSiemens Healthcare Diagnostics Inc.PDJ2018-07-06
04987486015093ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
04987486015109ELUENT 80BARKRAY USA, INC.PDJ2018-02-08
04987486015116ELUENT 80CVARKRAY USA, INC.PDJ2018-02-08
14987486015090ELUENT 80AARKRAY USA, INC.PDJ2018-02-08
14987486015106ELUENT 80BARKRAY USA, INC.PDJ2018-02-08
14987486015113ELUENT 80CVARKRAY USA, INC.PDJ2018-02-08