GGT Assay 334-10

GUDID 00628063400508

SEKISUI DIAGNOSTICS, LLC

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry
Primary Device ID00628063400508
NIH Device Record Key15856530-8500-4747-b5dd-aab2396f4412
Commercial Distribution StatusIn Commercial Distribution
Brand NameGGT Assay
Version Model Number334-10
Catalog Number334-10
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
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
GS100628063400508 [Primary]

FDA Product Code

JQBKINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

On-Brand Devices [GGT Assay]

00628063401093SK334-20
00628063400508334-10

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