MAS Diabetes Liquid Assayed Diabetes Control

GUDID 00884883004429

Microgenics Corporation

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 00884883004429
• NIH Device Record Key: fedf0e19-bfbc-4536-8824-88494bf236ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAS Diabetes Liquid Assayed Diabetes Control
• Version Model Number: DBCL-V
• 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: 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	00884883004429 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042717

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2019-04-30
• Device Publish Date: 2017-09-28

On-Brand Devices [MAS Diabetes Liquid Assayed Diabetes Control]

• 00884883004429: DBCL-V
• 00884883003521: DBCL-S
• 00884883003514: DBCL-MP