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Dimension Vista® Flex® reagent cartridge CRBM

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Vista® Flex® reagent cartridge CRBM FDA UDI
Generic Name
Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Carbamazepine Flex® reagent cartridgem, 80 tests FDA UDI
Model / Reference
10445129 FDA UDI
Description
Carbamazepine Flex® reagent cartridgem, 80 tests FDA UDI

Identifiers

Catalog Number
K4087 FDA UDI
Primary DI / UDI-DI
00842768015137 FDA UDI
510(k) Number
K061020 FDA UDI
FDA Product Code
KLT FDA UDI
GMDN Term
Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3645 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: Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K061020 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 4ad63d7c-5f8a-4077-b529-b75be99110ec 37 fields · synced May 31, 2026