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Dimension Vista® Flex® reagent cartridge LITH

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge LITH FDA UDI
Generic Name
Lithium therapeutic drug monitoring IVD, kit, spectrophotometry FDA UDI
Device Name
Lithium Flex® reagent cartridge, 180 tests FDA UDI
Model / Reference
10635870 FDA UDI
Description
Lithium Flex® reagent cartridge, 180 tests FDA UDI

Identifiers

Catalog Number
K4150 FDA UDI
Primary DI / UDI-DI
00842768035326 FDA UDI
510(k) Number
K112142 FDA UDI
FDA Product Code
NDW FDA UDI
GMDN Term
Lithium therapeutic drug monitoring IVD, kit, spectrophotometry 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

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

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, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge LITH by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lithium therapeutic drug monitoring IVD, kit, spectrophotometry.

Cleared under the same submission

K112142 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics

Sources (1)

  • FDA UDI 440b2e8e-0447-41da-9ca7-efb8abf8224b 37 fields · synced Jun 8, 2026