Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 08057796190

GUDID 07613336121252

Roche Diagnostics GmbH

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry
Primary Device ID07613336121252
NIH Device Record Key8a440280-2cb6-420d-ac6a-0b0c68ac61a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
Version Model Number08057796190
Catalog Number08057796190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336121252 [Primary]

FDA Product Code

JQBKINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-18
Device Publish Date2020-03-10

On-Brand Devices [Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz]

0761333612125208057796190
040156309268555401461190
040156309250185168775190
040156309165113002721122

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