Hema-Trol

GUDID 00884883005853

Microgenics Corporation

Haemoglobin detection IVD, control

• Primary Device ID: 00884883005853
• NIH Device Record Key: b6e3eff2-02c8-4801-bfee-17f359d5a3d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hema-Trol
• Version Model Number: HYC84668
• Company DUNS: 122153799
• Company Name: Microgenics Corporation
• 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: 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	00884883005853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853776

FDA Product Code

• JPK: Mixture, Hematology Quality Control

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: 2016-09-21

On-Brand Devices [Hema-Trol]

• 00884883005860: HYC84669
• 00884883005853: HYC84668
• 00884883005846: HYC84667
• 00884883005839: HYC84666