CEDIA Heroin Metabolite (6-AM) Assay

GUDID 00884883004245

Microgenics Corporation

6-Acetyl morphine IVD, reagent

• Primary Device ID: 00884883004245
• NIH Device Record Key: 709bc4f5-0e4e-4892-a6ee-8d4a6ac14f82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEDIA Heroin Metabolite (6-AM) Assay
• Version Model Number: 100108
• 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	00884883004245 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173183

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates
• 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: 5
• Public Version Date: 2019-04-30
• Device Publish Date: 2016-09-22

On-Brand Devices [CEDIA Heroin Metabolite (6-AM) Assay]

• 00884883011366: 10015213
• 00884883004306: 100186
• 00884883004245: 100108
• 00884883001558: 100107