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i-STAT

FDA UDI

Class II (US FDA UDI)

by Abbott Point of Care Inc.

Identity

Trade Name
i-STAT FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent FDA UDI
Device Name
CK-MB Cartridge FDA UDI
Model / Reference
03P92-25 FDA UDI
Description
CK-MB Cartridge FDA UDI

Identifiers

Catalog Number
03P92-25 FDA UDI
Primary DI / UDI-DI
10054749000200 FDA UDI
510(k) Number
K051433 FDA UDI
FDA Product Code
MYT FDA UDI
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagent 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

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, reagent

i-STAT by Abbott Point of Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Point of Care Inc.

Sources (1)

  • FDA UDI 093f0304-998e-4b59-b2a6-124ad308eba6 37 fields · synced Jun 9, 2026