← Back to catalogue

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, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT iValproic Acid Reagent Kit FDA UDI
Model / Reference
1P35-25 FDA UDI
Description
ARCHITECT iValproic Acid Reagent Kit FDA UDI

Identifiers

Catalog Number
01P3525 FDA UDI
Primary DI / UDI-DI
00380740001827 FDA UDI
FDA Product Code
DLJ FDA UDI
LEG FDA UDI
GMDN Term
Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 FDA UDI
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, chemiluminescent immunoassay

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, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Abbott Laboratories, Inc.

Sources (1)

  • FDA UDI 3218f2d6-2c37-40b6-8f1d-f30d0a87a6ea 36 fields · synced May 30, 2026