CEDIA Negative Calibrator

GUDID 00884883011489

Microgenics Corporation

Multiple drugs of abuse IVD, calibrator

• Primary Device ID: 00884883011489
• NIH Device Record Key: 23beb518-321f-41a3-8645-30a52a614d9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Negative Calibrator
• Version Model Number: 1557416
• 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	00884883011489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935793

FDA Product Code

• DKB: Calibrators, Drug Mixture

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: 2019-05-01
• Device Publish Date: 2016-09-12

On-Brand Devices [CEDIA Negative Calibrator ]

• 00884883011489: 1557416
• 00884883006065: 10021390
• 00884883001961: 1661388