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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott Ireland Diagnostics

Identity

Trade Name
Alinity FDA UDI
Generic Name
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Alinity i BRAHMS PCT Reagent Kit 200 Tests FDA UDI
Model / Reference
01R1821 FDA UDI
Description
Alinity i BRAHMS PCT Reagent Kit 200 Tests FDA UDI

Identifiers

Catalog Number
01R1821 FDA UDI
Primary DI / UDI-DI
00380740153953 FDA UDI
FDA Product Code
PMT FDA UDI
PRI FDA UDI
PTF FDA UDI
GMDN Term
Procalcitonin (PCT) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3215 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: Procalcitonin (PCT) 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 Procalcitonin (PCT) 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 38fcfc98-9be1-42fb-ba8e-9a1ae6616a01 36 fields · synced May 29, 2026