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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
Alinity FDA UDI
Generic Name
Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Alinity i STAT CK-MB Reagent Kit 200 Tests FDA UDI
Model / Reference
04V3821 FDA UDI
Description
Alinity i STAT CK-MB Reagent Kit 200 Tests FDA UDI

Identifiers

Catalog Number
04V3821 FDA UDI
Primary DI / UDI-DI
00380740174927 FDA UDI
FDA Product Code
JHX 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
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

Alinity 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 772d0031-0400-4e26-8091-8a0a6d202e1c 36 fields · synced Jun 8, 2026