ENVOY 500 CK REAGENT KIT

GUDID 03661540201707

ELITECH CLINICAL SYSTEMS SAS

Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry Total creatine kinase (CK) IVD, kit, spectrophotometry

• Primary Device ID: 03661540201707
• NIH Device Record Key: 820c1173-51c7-4959-9013-ea2019c351d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENVOY 500 CK REAGENT KIT
• Version Model Number: 55327
• 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	03661540201707 [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: 2023-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ELITECH CLINICAL SYSTEMS SAS

• 03661540200908 - ENVOY 500 AMYLASE REAGENT KIT: 2023-07-06
• 03661540201004 - ENVOY 500 AST REAGENT KIT: 2023-07-06
• 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
• 03661540201707 - ENVOY 500 CK REAGENT KIT: 2023-07-06
• 03661540202001 - ENVOY 500 IRON REAGENT KIT: 2023-07-06