Fluxergy Analyzer 5506-CE

GUDID 00850027856124

Fluxergy, Inc.

Thermal cycler nucleic acid amplification analyser IVD, point-of-care

• Primary Device ID: 00850027856124
• NIH Device Record Key: ef1c5d17-e24a-48a1-93da-73c0a3c3cd2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fluxergy Analyzer
• Version Model Number: Mk12.1
• Catalog Number: 5506-CE
• Company DUNS: 059765569
• Company Name: Fluxergy, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850027856124 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-31
• Device Publish Date: 2021-05-21