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Alinity

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
Alinity FDA UDI
Generic Name
Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Alinity c Amikacin Reagent Kit 200 Tests FDA UDI
Model / Reference
09P4420 FDA UDI
Description
Alinity c Amikacin Reagent Kit 200 Tests FDA UDI

Identifiers

Catalog Number
09P4420 FDA UDI
Primary DI / UDI-DI
00380740154103 FDA UDI
510(k) Number
K052815 FDA UDI
FDA Product Code
KLQ FDA UDI
GMDN Term
Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3035 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: Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

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

Similar devices

Also classified as Amikacin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry.

Cleared under the same submission

K052815 also covers:

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 05708912-45c3-4abc-8d58-8533b3a14b64 37 fields · synced May 31, 2026