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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Phenytoin therapeutic drug monitoring IVD, calibrator FDA UDI
Device Name
ARCHITECT iPhenytoin Calibrators FDA UDI
Model / Reference
1P34-01 FDA UDI
Description
ARCHITECT iPhenytoin Calibrators FDA UDI

Identifiers

Catalog Number
01P3401 FDA UDI
Primary DI / UDI-DI
00380740001797 FDA UDI
FDA Product Code
DIP FDA UDI
LGR FDA UDI
GMDN Term
Phenytoin therapeutic drug monitoring IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3350 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: Phenytoin therapeutic drug monitoring IVD, calibrator

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

Similar devices

Also classified as Phenytoin therapeutic drug monitoring IVD, calibrator.

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 28316e15-63d0-413d-aa8f-f452c95c4f1a 36 fields · synced Jun 8, 2026