Gentian Cystatin C Control Kit (2 x 1mL)

GUDID 17090038460020

Gentian AS

Cystatin C IVD, control

• Primary Device ID: 17090038460020
• NIH Device Record Key: b59fa431-2a2c-42e1-b455-f24d20669bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gentian Cystatin C Control Kit (2 x 1mL)
• Version Model Number: 1019 / A52765
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17090038460020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081875

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: 2016-09-24

On-Brand Devices [Gentian Cystatin C Control Kit (2 x 1mL)]

• 07090038460078: The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibrati
• 17090038460020: 1019 / A52765