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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT iCarbamazepine Reagent Kit FDA UDI
Model / Reference
1P36-27 FDA UDI
Description
ARCHITECT iCarbamazepine Reagent Kit FDA UDI

Identifiers

Catalog Number
01P3627 FDA UDI
Primary DI / UDI-DI
00380740081072 FDA UDI
510(k) Number
K103627 FDA UDI
FDA Product Code
KLT FDA UDI
DKB FDA UDI
GMDN Term
Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3645 FDA UDI
862.3200 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, chemiluminescent immunoassay

Architect by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay.

Cleared under the same submission

K103627 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott

Sources (1)

  • FDA UDI f9f4cfb7-eba2-40d9-abe4-763debe2ddd1 37 fields · synced May 30, 2026