EON 300 CREATININE REAGENT

GUDID 03661540200519

ELITECH CLINICAL SYSTEMS SAS

Creatinine IVD, kit, enzyme spectrophotometry Creatinine IVD, kit, enzyme spectrophotometry Creatinine IVD, kit, enzyme spectrophotometry Creatinine IVD, kit, enzyme spectrophotometry Creatinine IVD, kit, enzyme spectrophotometry

Primary Device ID	03661540200519
NIH Device Record Key	c8d7a78a-6f8c-4f1c-a8dd-7128f7b75fe3
Commercial Distribution Discontinuation	2020-09-17
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	EON 300 CREATININE REAGENT
Version Model Number	79331
Company DUNS	267732378
Company Name	ELITECH CLINICAL SYSTEMS SAS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540200519 [Primary]

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2022-05-26
Device Publish Date	2016-09-24

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03661540201202 - ENVOY 500 DIRECT BILIRUBIN REAGENT KIT	2023-07-06
03661540201301 - ENVOY 500 TOTAL BILIRUBIN REAGENT KIT	2023-07-06
03661540201400 - ENVOY 500 CALCIUM REAGENT KIT	2023-07-06
03661540201608 - ENVOY 500 CHOLESTEROL REAGENT KIT	2023-07-06
03661540201707 - ENVOY 500 CK REAGENT KIT	2023-07-06
03661540202001 - ENVOY 500 IRON REAGENT KIT	2023-07-06