gudid Primary ID: 27302

Beckman Coulter PK Systems Anti-B (164B5G10+7821D9) (UDI 27302)

Manufactured by DIAGAST

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Beckman Coulter PK Systems Anti-B (164B5G10+7821D9) (Model/Catalog Number: 27302) is a medical device manufactured by DIAGAST. This product is indexed under FDA Product Code / Category Classification within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 27302
Product Code / EMDN: N/A
Device Name: Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter PK Systems
Database Sync Date: 2026-08-09 10:01:36

Full Regulatory Attributes

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{
    "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 Beckman Coulter PK Systems Anti-B (164B5G10+7821D9)?

The registered manufacturer of record for Beckman Coulter PK Systems Anti-B (164B5G10+7821D9) is DIAGAST.

What is the Primary UDI-DI identifier for Beckman Coulter PK Systems Anti-B (164B5G10+7821D9)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 27302.

What classification code is assigned to this device?

This device is registered under product classification code .

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