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Stratus® CS Acute Care™ CKMB TestPak

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Stratus® CS Acute Care™ CKMB TestPak FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Stratus® CS Acute Care (TM) CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E. C. No. 2.7.3.2) in heparinized plasma. FDA UDI
Model / Reference
10445068 FDA UDI
Description
The Stratus® CS Acute Care (TM) CKMB method is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase (ATP: Creatine N-Phosphostransferase, E. C. No. 2.7.3.2) in heparinized plasma. FDA UDI

Identifiers

Catalog Number
CCKMB FDA UDI
Primary DI / UDI-DI
00842768004490 FDA UDI
510(k) Number
K051650 FDA UDI
FDA Product Code
DDR FDA UDI
JHX FDA UDI
MMI FDA UDI
JIT FDA UDI
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5680 FDA UDI
862.1215 FDA UDI
862.1150 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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, fluorescent immunoassay

Stratus® CS Acute Care™ CKMB TestPak 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, fluorescent immunoassay.

Cleared under the same submission

K051650 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 95bf443e-75d5-4af0-a7c1-9412eb97b120 37 fields · synced May 30, 2026