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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT Cyclosporine Reagent Kit FDA UDI
Model / Reference
1L75-25 FDA UDI
Description
ARCHITECT Cyclosporine Reagent Kit FDA UDI

Identifiers

Catalog Number
01L7525 FDA UDI
Primary DI / UDI-DI
00380740001315 FDA UDI
FDA Product Code
DLJ FDA UDI
MKW FDA UDI
GMDN Term
Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.3200 FDA UDI
862.1235 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: Cyclosporin A/cyclosporine 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 Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay.

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 d5f22a8d-831c-4840-b41b-36dfabbef31a 36 fields · synced Jun 8, 2026