FDA.report

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

Primary DI
04560189282926
Brand
Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Company
TOSOH CORPORATION
Model
HLC-723G8 LA
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LCPAssay, Glycosylated Hemoglobin

Product Code Classifications

CodeDeviceSpecialtyClass
LCPAssay, Glycosylated HemoglobinHematology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04560189282926PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and store indoors

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
690571724
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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