Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

Primary DI
04560189282919
Brand
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Company
TOSOH CORPORATION
Model
HLC-723G8
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560189282919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560189282919045601892829194560189282919

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and store indoors

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
614-317-1909Levent.durukan@tosoh.com
650-615-8134Dave.Wurtz@Tosoh.com

Regulatory Flags#

DUNS number
690571724
Device count
1
Premarket exempt
true
Serial number
true

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04560189211759AIA-PACK WASH CONCENTRATEN/A2019-09-02
04560189211766AIA-PACK DILUENT CONCENTRATEN/A2019-09-02
14560189210056AIA-PACK TSH 3rd-GenN/A2016-09-24
14560189210063ST AIA-PACK BetaHCGN/A2016-09-24
14560189210094ST AIA-PACK MyoglobinN/A2016-09-24
14560189210155ST AIA-PACK IgEIIN/A2016-09-24
14560189210230ST AIA-PACK AFPN/A2016-09-24
14560189210261ST AIA-PACK BMGN/A2016-09-24
14560189210315ST AIA-PACK FT4N/A2016-09-24

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