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Dimension® Flex® reagent cartridge LI

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Flex® reagent cartridge LI FDA UDI
Generic Name
Lithium therapeutic drug monitoring IVD, kit, spectrophotometry FDA UDI
Device Name
Lithium Flex® reagent cartridge, 80 tests FDA UDI
Model / Reference
10444939 FDA UDI
Description
Lithium Flex® reagent cartridge, 80 tests FDA UDI

Identifiers

Catalog Number
DF132 FDA UDI
Primary DI / UDI-DI
00842768005367 FDA UDI
510(k) Number
K011033 FDA UDI
FDA Product Code
JIH 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® Flex® reagent cartridge LI 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.

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 3027de3f-d100-44af-b53f-dc72122e45b0 37 fields · synced May 31, 2026