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Dimension® Flex® reagent cartridge MBI

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension® Flex® reagent cartridge MBI FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry FDA UDI
Device Name
Creatine Kinase MB Flex® reagent cartridge, 120 tests FDA UDI
Model / Reference
10464510 FDA UDI
Description
Creatine Kinase MB Flex® reagent cartridge, 120 tests FDA UDI

Identifiers

Catalog Number
DF32 FDA UDI
Primary DI / UDI-DI
00842768025556 FDA UDI
510(k) Number
K081731 FDA UDI
FDA Product Code
CGS FDA UDI
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1215 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: Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry

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

Similar devices

Also classified as Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry.

Cleared under the same submission

K081731 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 1fe9f3a3-f534-4276-9068-449ca16f2943 37 fields · synced Jun 8, 2026