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pma Primary ID: P980041

IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (UDI P980041)

Manufactured by Beckman Coulter, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS - Primary ID P980041

Device Regulatory Overview

The IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS (Model/Catalog Number: Unspecified) is a medical device manufactured by Beckman Coulter, Inc.. This product is indexed under FDA Product Code / Category Classification LOK within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1922-2026 View Full Alert →

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ID: Z-2115-2025 View Full Alert →

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850...

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ID: Z-1794-2026 View Full Alert →

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative ...

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Technical Specifications

Model Number
N/A
Product Code / EMDN
LOK
Device Name
KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTS
Database Sync Date
2026-08-09 10:06:20

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS?

The registered manufacturer of record for IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS is Beckman Coulter, Inc..

What is the Primary UDI-DI identifier for IN VITRO DIAGNOSTIC PRODUCT ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P980041.

What classification code is assigned to this device?

This device is registered under product classification code LOK.

Similar Classification Devices (LOK)

Other Devices by Beckman Coulter, Inc.

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