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gudid Primary ID: C28649

Access AFP (UDI C28649)

Manufactured by Beckman Coulter, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Access AFP - Primary ID C28649

Device Regulatory Overview

The Access AFP (Model/Catalog Number: C28649) 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 →

Access Total T4 Calibrator, Catalog No. 33805...

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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
C28649
Product Code / EMDN
LOK
Device Name
The Access AFP assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative determination of alpha-fetoprotein (AFP) in:1. Human serum, as an aid in the management of patients with non-seminomatous testicular cancer.2. Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amniography.
Database Sync Date
2026-08-09 09:22:50

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 Access AFP?

The registered manufacturer of record for Access AFP is Beckman Coulter, Inc..

What is the Primary UDI-DI identifier for Access AFP?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is C28649.

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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