gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 3002721122

GUDID 04015630916511

Roche Diagnostics GmbH

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry
Primary Device ID04015630916511
NIH Device Record Key35f4e530-57a1-4843-8a5f-f22a8323dfdb
Commercial Distribution StatusIn Commercial Distribution
Brand Namegamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
Version Model Number3002721122
Catalog Number3002721122
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630916511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-01-28
Device Publish Date2021-01-20

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

0761333612125208057796190
040156309268555401461190
040156309250185168775190
040156309165113002721122

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