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Dimension® Flex® reagent cartridge MALB

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Flex® reagent cartridge MALB FDA UDI
Generic Name
Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Microalbumin Flex® reagent cartridge, 80 tests FDA UDI
Model / Reference
10444977 FDA UDI
Description
Microalbumin Flex® reagent cartridge, 80 tests FDA UDI

Identifiers

Catalog Number
DF114 FDA UDI
Primary DI / UDI-DI
00842768005312 FDA UDI
510(k) Number
K033525 FDA UDI
FDA Product Code
DCF FDA UDI
GMDN Term
Microalbumin IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5040 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: Microalbumin IVD, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Microalbumin IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K033525 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 dd7b8388-b44e-471c-a7fc-e8c8660628e5 37 fields · synced May 30, 2026