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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry FDA UDI
Device Name
Valproic Acid FDA UDI
Model / Reference
1E13-20 FDA UDI
Description
Valproic Acid FDA UDI

Identifiers

Catalog Number
01E1320 FDA UDI
Primary DI / UDI-DI
00380740000332 FDA UDI
510(k) Number
K030405 FDA UDI
FDA Product Code
LEG FDA UDI
GMDN Term
Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry 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: Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

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

Similar devices

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

Cleared under the same submission

K030405 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 06a92ff5-8e45-4d21-be08-349b54230559 37 fields · synced Jun 8, 2026