Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Urea IVD, reagent FDA UDI
Device Name: Urea Nitrogen FDA UDI
Model / Reference: 7D75-22 FDA UDI
Description: Urea Nitrogen FDA UDI

Identifiers

Catalog Number: 07D7522 FDA UDI
Primary DI / UDI-DI: 00380740161774 FDA UDI
FDA Product Code: CDQ FDA UDI
GMDN Term: Urea IVD, reagent FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Urea IVD, reagent

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

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Teco Diagnostics Urea Nitrogen (BUN) Reagent Set — TECO DIAGNOSTICS · Class II
i-STAT — Abbott Point of Care Inc. · Class II
Piccolo Comprehensive Metabolic Panel — ABAXIS, INC. · Class II
UREA — Randox Laboratories, Ltd. · Class II
ACE — Alfa Wassermann, Inc. · Class II
Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Abbott

Sources (1)

FDA UDI 483156bc-f4d8-4882-8467-188c042cb34f 36 fields · synced May 31, 2026