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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
Alinity FDA UDI
Generic Name
Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
Alinity i Homocysteine Reagent Kit 200 Tests FDA UDI
Model / Reference
09P2820 FDA UDI
Description
Alinity i Homocysteine Reagent Kit 200 Tests FDA UDI

Identifiers

Catalog Number
09P2820 FDA UDI
Primary DI / UDI-DI
00380740153496 FDA UDI
FDA Product Code
LPS FDA UDI
GMDN Term
Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1377 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: Homocysteine IVD, kit, chemiluminescent immunoassay

Alinity by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Homocysteine IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI eafd6625-d83f-49ff-b62c-eaec59f80366 36 fields · synced Jun 1, 2026