Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name: ARCHITECT FDA UDI
Generic Name: Lipoprotein A IVD, control FDA UDI
Device Name: Lp(a) Control FDA UDI
Model / Reference: 5P84-10 FDA UDI
Description: Lp(a) Control FDA UDI

Identifiers

Catalog Number: 05P8410 FDA UDI
Primary DI / UDI-DI: 00380740100933 FDA UDI
FDA Product Code: JIT FDA UDI
JJX FDA UDI
GMDN Term: Lipoprotein A IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1150 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: Lipoprotein A IVD, control

Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lipoprotein A IVD, control.

N Lp(a) Control SY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
N Lp(a) Control SY — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
Diazyme — Diazyme Laboratories, Inc.
Lp(a) Control Set — Sentinel Ch. Srl · Class I
Pointe Lipoprotein (a) Control Set — POINTE SCIENTIFIC, INC. · Class I
Diazyme — Diazyme Laboratories, Inc.

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 Laboratories, Inc.

Sources (1)

FDA UDI bcb3d8e5-f345-4429-8083-34a604e692c9 36 fields · synced May 30, 2026