← Back to catalogue

Globe Scientific

FDA UDI

Class I (US FDA UDI)

by Globe Scientific, Llc

Identity

Trade Name
Globe Scientific FDA UDI
Generic Name
Laboratory analyser cuvette IVD, single-use FDA UDI
Device Name
COBAS MIRA: Cuvette, for use with Cobas Mira, Mira S, Mira Plus and Horiba ABX Mira Plus analyzers, Individually Wrapped, 50/Box, 10 Boxes/Unit FDA UDI
Model / Reference
5120 FDA UDI
Description
COBAS MIRA: Cuvette, for use with Cobas Mira, Mira S, Mira Plus and Horiba ABX Mira Plus analyzers, Individually Wrapped, 50/Box, 10 Boxes/Unit FDA UDI

Identifiers

Primary DI / UDI-DI
00840095606356 FDA UDI
FDA Product Code
LXG FDA UDI
GMDN Term
Laboratory analyser cuvette IVD, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Laboratory analyser cuvette IVD, single-use

Globe Scientific by Globe Scientific, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laboratory analyser cuvette IVD, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Globe Scientific, Llc

Sources (1)

  • FDA UDI c50ef340-f02a-467e-a93a-7ef008d774fa 33 fields · synced May 30, 2026