FDA.reportPublic FDA data

Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz

Primary DI
07613336121252
Brand
Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
Company
Roche Diagnostics GmbH
Model
08057796190
Catalog number
08057796190
Published
2020-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JQBKINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336121252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336121252076133361212527613336121252

GMDN Terms#

Term, Definition table
TermDefinition
Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen, using an enzyme spectrophotometry method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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