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Li 2

FDA UDI

Class II (US FDA UDI)

by Randox Laboratories, Ltd.

Identity

Trade Name
Li 2 FDA UDI
Generic Name
Lithium therapeutic drug monitoring IVD, reagent FDA UDI
Device Name
The product is intended for the quantitative in vitro determination of Lithium in serum. FDA UDI
Model / Reference
LM4005 FDA UDI
Description
The product is intended for the quantitative in vitro determination of Lithium in serum. FDA UDI

Identifiers

Catalog Number
LM4005 FDA UDI
Primary DI / UDI-DI
05055273209143 FDA UDI
510(k) Number
K050374 FDA UDI
FDA Product Code
NDW 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

Yes

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

Li 2 by Randox Laboratories, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lithium therapeutic drug monitoring IVD, reagent.

Cleared under the same submission

K050374 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA UDI b0172003-70c6-4649-96ca-0fc2148a55fd 37 fields · synced May 30, 2026