GUDIDData
gudid Primary ID: 0066428

Anti-S (Monoclonal) Gamma-clone (UDI 0066428)

Manufactured by IMMUCOR, INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Anti-S (Monoclonal) Gamma-clone - Primary ID 0066428

Device Regulatory Overview

The Anti-S (Monoclonal) Gamma-clone (Model/Catalog Number: 0066428) is a medical device manufactured by IMMUCOR, INC.. This product is indexed under FDA Product Code / Category Classification within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
0066428
Product Code / EMDN
N/A
Device Name
Anti-S (Monoclonal) Gamma-clone reagent is intended for the detection of the S (MNS3) antigen on red blood cells by tube test.
Database Sync Date
2026-08-09 09:39:01

Full Regulatory Attributes

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Anti-S (Monoclonal) Gamma-clone?

The registered manufacturer of record for Anti-S (Monoclonal) Gamma-clone is IMMUCOR, INC..

What is the Primary UDI-DI identifier for Anti-S (Monoclonal) Gamma-clone?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0066428.

What classification code is assigned to this device?

This device is registered under product classification code .

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint