Architect

FDA UDI

Class II (US FDA UDI)

by Abbott

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Homocysteine IVD, control FDA UDI
Device Name: ARCHITECT Homocysteine Controls FDA UDI
Model / Reference: 1L71-10 FDA UDI
Description: ARCHITECT Homocysteine Controls FDA UDI

Identifiers

Catalog Number: 01L7110 FDA UDI
Primary DI / UDI-DI: 00380740001230 FDA UDI
FDA Product Code: JIT FDA UDI
LPS FDA UDI
JJX FDA UDI
GMDN Term: Homocysteine IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 FDA UDI
862.1377 FDA UDI
862.1660 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: Homocysteine IVD, control

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

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Liquichek — Bio-Rad Laboratories · Class I
Audit MicroControls Control LQ Homocysteine — Aalto Scientific, Ltd. · Class I
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ADVIA Centaur® HCY MCM — Siemens Healthcare Diagnostics · Class I
CAROLINA LIQUID CHEMISTRIES CORP.® HCY LEVEL 3 CONTROL KIT PART# CC053 — Carolina Liquid Chemistries Corp. · Class I

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 a3d5be91-27e9-48f6-baac-c38f7db1edb1 36 fields · synced Jun 6, 2026