← Back to catalogue

Vitros

FDA UDI

Class II (US FDA UDI)

by Ortho-Clinical Diagnostics

Identity

Trade Name
VITROS FDA UDI
Generic Name
Lithium therapeutic drug monitoring IVD, reagent FDA UDI
Device Name
VITROS Chemistry Products Li Slides FDA UDI
Model / Reference
8318925 FDA UDI
Description
VITROS Chemistry Products Li Slides FDA UDI

Identifiers

Catalog Number
8318925 FDA UDI
Primary DI / UDI-DI
10758750004720 FDA UDI
FDA Product Code
JIH FDA UDI
GMDN Term
Lithium therapeutic drug monitoring IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3560 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: Lithium therapeutic drug monitoring IVD, reagent

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

Similar devices

Also classified as Lithium therapeutic drug monitoring 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

Manufacturer
Ortho-Clinical Diagnostics

Sources (1)

  • FDA UDI 1665a927-28fe-4674-be04-dbeccf2130e8 35 fields · synced May 29, 2026