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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
HITACHI: Cuvette, for use with the Hitachi 902 analyzer, 6/Set, 4 Sets/Unit (Note: New packaging) ** SPECIAL ORDER ITEM ** FDA UDI
Model / Reference
5133 FDA UDI
Description
HITACHI: Cuvette, for use with the Hitachi 902 analyzer, 6/Set, 4 Sets/Unit (Note: New packaging) ** SPECIAL ORDER ITEM ** FDA UDI

Identifiers

Primary DI / UDI-DI
00840095607469 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

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Manufacturer

Manufacturer
Globe Scientific, Llc

Sources (1)

  • FDA UDI 97b4bb2f-9f99-4b2b-a151-82057a99c879 33 fields · synced Jun 7, 2026