GGT Assay SK334-20

GUDID 00628063401093

SEKISUI DIAGNOSTICS, LLC

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry
Primary Device ID00628063401093
NIH Device Record Keya4630bb5-533b-4e9a-874a-bf04c88a6ed6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGGT Assay
Version Model NumberSK334-20
Catalog NumberSK334-20
Company DUNS966812344
Company NameSEKISUI DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100628063401093 [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 Date2018-10-25
Device Publish Date2018-09-24

On-Brand Devices [GGT Assay]

00628063401093SK334-20
00628063400508334-10

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