Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Ireland

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Buffered sample diluent IVD FDA UDI
Device Name: ARCHITECT Folate Manual Diluent FDA UDI
Model / Reference: 1P74-50 FDA UDI
Description: ARCHITECT Folate Manual Diluent FDA UDI

Identifiers

Catalog Number: 01P7450 FDA UDI
Primary DI / UDI-DI: 00380740002176 FDA UDI
FDA Product Code: JJX FDA UDI
CGN FDA UDI
JIT FDA UDI
GMDN Term: Buffered sample diluent IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
862.1295 FDA UDI
862.1150 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: Buffered sample diluent IVD

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

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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 I	Pending data

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Manufacturer

Manufacturer: Abbott Ireland

Sources (1)

FDA UDI b2fc338d-c36c-478b-b680-5bfa102a517b 36 fields · synced May 29, 2026