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Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge FDA UDI
Generic Name
Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests FDA UDI
Model / Reference
10444904 FDA UDI
Description
Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests FDA UDI

Identifiers

Catalog Number
RF420 FDA UDI
Primary DI / UDI-DI
00842768013829 FDA UDI
510(k) Number
K970343 FDA UDI
FDA Product Code
JHY FDA UDI
GMDN Term
Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA) 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: Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)

Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K970343 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 b28c4327-1044-4aff-83ba-29cd624ff3be 37 fields · synced May 30, 2026