← Back to catalogue

Vitros

FDA UDI

Class I (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS FDA UDI
Generic Name
Magnesium (Mg2+) IVD, reagent FDA UDI
Device Name
VITROS Chemistry Products Mg Slides FDA UDI
Model / Reference
8255093 FDA UDI
Description
VITROS Chemistry Products Mg Slides FDA UDI

Identifiers

Catalog Number
8255093 FDA UDI
Primary DI / UDI-DI
10758750004621 FDA UDI
FDA Product Code
JGJ FDA UDI
GMDN Term
Magnesium (Mg2+) IVD, reagent FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1495 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Magnesium (Mg2+) IVD, reagent

Vitros by Ortho-Clinical Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnesium (Mg2+) IVD, reagent.

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

Sources (1)

  • FDA UDI d52461c5-f33a-4d04-8587-dfc418f8df5d 35 fields · synced May 30, 2026