Envoy 03-07051-01

GUDID 08033622964551

Multiple clinical chemistry analyser IVD, laboratory, semi-automated: An electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or multiple technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.

BIOTECNICA INSTRUMENTS SPA

Multiple clinical chemistry analyser IVD, laboratory, semi-automated

• Primary Device ID: 08033622964551
• NIH Device Record Key: 5e3526fb-0f60-4476-bbf7-6d6294df9b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Envoy
• Version Model Number: Envoy 500+ S/I
• Catalog Number: 03-07051-01
• Company DUNS: 436575930
• Company Name: BIOTECNICA INSTRUMENTS SPA
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033622964551 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), 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: 2020-09-30
• Device Publish Date: 2020-09-22

On-Brand Devices [Envoy]

• 08033622964551: Multiple clinical chemistry analyser IVD, laboratory, semi-automated: An electrically-powered la
• 08033622963257: Multiple clinical chemistry analyser IVD, laboratory, semi-automated: An electrically-powered la