ZEUS dIFine(R) FA08IMG

GUDID 00845533001861

ZEUS dIFine® digital immunofluorescence system is an IFA imaging and pattern recognition instrument designed to acquire, analyze, display and store digital images of ZEUS IFA slides. It consists of an automated digital scanner with intelligent software.

ZEUS SCIENTIFIC, INC.

Fluorescent immunoassay analyser IVD, laboratory, automated

• Primary Device ID: 00845533001861
• NIH Device Record Key: 56832619-a1ee-42de-bfb8-1333fdf40484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZEUS dIFine(R)
• Version Model Number: FA08IMG
• Catalog Number: FA08IMG
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00845533001861 [Primary]

FDA Product Code

• JMM: Column Chromatography & Color Development, Hydroxyproline
• PIV: Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

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: 2022-05-11
• Device Publish Date: 2022-05-03

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