MAGNESIUM XYLIDYL

GUDID 03661540216107

ELITECH CLINICAL SYSTEMS SAS

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Primary Device ID03661540216107
NIH Device Record Keyb699c53f-887c-4b01-af02-cf633a61b394
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAGNESIUM XYLIDYL
Version Model NumberMAGX-0230
Company DUNS267732378
Company NameELITECH CLINICAL SYSTEMS SAS
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
GS103661540216107 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-07-06
Device Publish Date2016-09-24

Devices Manufactured by ELITECH CLINICAL SYSTEMS SAS

03661540200908 - ENVOY 500 AMYLASE REAGENT KIT2023-07-06
03661540201004 - ENVOY 500 AST REAGENT KIT2023-07-06
03661540201202 - ENVOY 500 DIRECT BILIRUBIN REAGENT KIT2023-07-06
03661540201301 - ENVOY 500 TOTAL BILIRUBIN REAGENT KIT2023-07-06
03661540201400 - ENVOY 500 CALCIUM REAGENT KIT2023-07-06
03661540201608 - ENVOY 500 CHOLESTEROL REAGENT KIT2023-07-06
03661540201707 - ENVOY 500 CK REAGENT KIT2023-07-06
03661540202001 - ENVOY 500 IRON REAGENT KIT2023-07-06

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