Architect

FDA UDI

Class I (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Chemiluminescent immunoassay analyser IVD FDA UDI
Device Name: ARCHITECT i1000SR FDA UDI
Model / Reference: 1L86-01 FDA UDI
Description: ARCHITECT i1000SR FDA UDI

Identifiers

Catalog Number: 01L8601 FDA UDI
Primary DI / UDI-DI: 00380740001537 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Chemiluminescent immunoassay analyser IVD FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Chemiluminescent immunoassay analyser IVD

Architect by Abbott Laboratories, Inc. — 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 Laboratories, Inc.

Sources (1)

FDA UDI 37e65e77-7dc5-4e32-928e-fe9a844b1f49 35 fields · synced Jun 1, 2026