MAS ChemTrak H Liquid Assayed Chemistry Control

GUDID 00884883004207

Microgenics Corporation

Multiple clinical chemistry analyte IVD, control

• Primary Device ID: 00884883004207
• NIH Device Record Key: b97812be-2ddf-4a85-937c-40dbed8865e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS ChemTrak H Liquid Assayed Chemistry Control
• Version Model Number: 10014152
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	00884883004207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092051

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-26
• Device Publish Date: 2017-09-28

On-Brand Devices [MAS ChemTrak H Liquid Assayed Chemistry Control]

• 00884883004207: 10014152
• 00884883004191: 10014151
• 00884883004184: 10014150