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Envoy

FDA UDI

Class I (US FDA UDI)

by Biotecnica Instruments Spa

Identity

Trade Name
Envoy FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory, semi-automated FDA UDI
Device Name
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. FDA UDI
Model / Reference
Envoy 500+ S/I FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
03-07051-01 FDA UDI
Primary DI / UDI-DI
08033622964551 FDA UDI
FDA Product Code
JJE FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory, semi-automated FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2160 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple clinical chemistry analyser IVD, laboratory, semi-automated

Envoy by Biotecnica Instruments Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple clinical chemistry analyser IVD, laboratory, semi-automated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biotecnica Instruments Spa

Sources (1)

  • FDA UDI 5e3526fb-0f60-4476-bbf7-6d6294df9b14 34 fields · synced May 30, 2026