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Dimension® CSA Flex® reagent cartridge

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® CSA Flex® reagent cartridge FDA UDI
Generic Name
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Cyclosporine Flex® reagent cartridge, 80 tests FDA UDI
Model / Reference
10285193 FDA UDI
Description
Cyclosporine Flex® reagent cartridge, 80 tests FDA UDI

Identifiers

Catalog Number
DF89A FDA UDI
Primary DI / UDI-DI
00842768025136 FDA UDI
510(k) Number
K023065 FDA UDI
FDA Product Code
MKW FDA UDI
GMDN Term
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1235 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: Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

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 31879ace-0bb8-4ae0-9ec0-c4dc8d46472b 37 fields · synced May 30, 2026