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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
Alinity FDA UDI
Generic Name
Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Alinity c Carbamazepine Reagent Kit 400 Test FDA UDI
Model / Reference
08P5820 FDA UDI
Description
Alinity c Carbamazepine Reagent Kit 400 Test FDA UDI

Identifiers

Catalog Number
08P5820 FDA UDI
Primary DI / UDI-DI
00380740135331 FDA UDI
510(k) Number
K123518 FDA UDI
FDA Product Code
KLT FDA UDI
GMDN Term
Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3645 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: Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Alinity by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Laboratories, Inc.

Sources (1)

  • FDA UDI efbdb53f-384e-4d27-b46b-ef7ea2169e78 37 fields · synced Jun 8, 2026