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Stratus® CS Acute Care™ CKMB CalPak

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name
Stratus® CS Acute Care™ CKMB CalPak FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay FDA UDI
Device Name
The Stratus® CS Acute Care (TM) CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care (TM) CKMB method. FDA UDI
Model / Reference
10445069 FDA UDI
Description
The Stratus® CS Acute Care (TM) CKMB Calibrator (CKMB CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care (TM) CKMB method. FDA UDI

Identifiers

Catalog Number
CCKMB-C FDA UDI
Primary DI / UDI-DI
00842768004506 FDA UDI
510(k) Number
K051650 FDA UDI
FDA Product Code
JIT FDA UDI
MMI FDA UDI
DDR FDA UDI
JHX FDA UDI
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 FDA UDI
862.1215 FDA UDI
866.5680 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 CalPak 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 a0224f30-c214-4c53-a6eb-6f9823fcfadf 37 fields · synced Jun 1, 2026