Gentian Cystatin C Single Use Control Low

GUDID 07090038460115

The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrato

Gentian AS

Cystatin C IVD, control

• Primary Device ID: 07090038460115
• NIH Device Record Key: 2bfcbd05-afa0-4a4e-bcc8-3cf6414cc125
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentian Cystatin C Single Use Control Low
• Version Model Number: 1029
• Company DUNS: 730958121
• Company Name: Gentian AS
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07090038460115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071388

FDA Product Code

• NDY: Test, Cystatin C

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: 2018-07-06
• Device Publish Date: 2016-11-18

Devices Manufactured by Gentian AS

• 17090038460013 - Gentian Cystatin C Reagent for the Beckman Coulter: 2018-07-06
• 17090038460020 - Gentian Cystatin C Control Kit (2 x 1mL): 2018-07-06
• 17090038460037 - Gentian Cystatin C Calibrator Kit: 2018-07-06
• 17090038460051 - Gentian Cystatin C Reagent Beckman Coulter UDR Kit: 2018-07-06
• 07090038460061 - Gentian Cystatin C Reagent Kit: 2018-07-06
• 07090038460078 - Gentian Cystatin C Control Kit (2 x 1mL): 2018-07-06 The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentia
• 07090038460085 - Gentian Cystatin C Control Kit (2 x 5mL): 2018-07-06 The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentia
• 07090038460092 - Gentian Cystatin C Calibrator: 2018-07-06 The Gentian Cystatin C Calibrator is intended to be used to establish a calibration curve for measuring Cystatin C concentration