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Dimension® Flex® reagent cartridge FERR

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Flex® reagent cartridge FERR FDA UDI
Generic Name
Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Ferritin Flex® reagent cartridge, 120 tests FDA UDI
Model / Reference
10444946 FDA UDI
Description
Ferritin Flex® reagent cartridge, 120 tests FDA UDI

Identifiers

Catalog Number
RF440 FDA UDI
Primary DI / UDI-DI
00842768013867 FDA UDI
FDA Product Code
JMG FDA UDI
GMDN Term
Ferritin IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5340 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: Ferritin IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Ferritin 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 4e85bab2-8932-4ca7-8aed-eb1c5b573461 36 fields · synced May 31, 2026