EON 100 PHOSPHORUS REAGENT

GUDID 03661540200243

ELITECH CLINICAL SYSTEMS SAS

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Primary Device ID03661540200243
NIH Device Record Keyf395a01f-6309-4429-828c-5a40dbb70b12
Commercial Distribution Discontinuation2020-09-16
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEON 100 PHOSPHORUS REAGENT
Version Model Number77415
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
GS103661540200243 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-05-26
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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