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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT STAT CK-MB Reagent Kit FDA UDI
Model / Reference
2K42-35 FDA UDI
Description
ARCHITECT STAT CK-MB Reagent Kit FDA UDI

Identifiers

Catalog Number
02K4235 FDA UDI
Primary DI / UDI-DI
00380740003265 FDA UDI
FDA Product Code
JHX FDA UDI
JIS FDA UDI
GMDN Term
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1215 FDA UDI
862.1150 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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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, chemiluminescent immunoassay

Architect by Abbott Ireland 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, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Ireland Diagnostics

Sources (1)

  • FDA UDI 70178306-3d06-4cbf-85ae-356b3cf5972f 36 fields · synced Jun 1, 2026