GUDIDData
eudamed_udi Primary ID: 05051700018975

Optilite® Anti-streptolysin O Control Pack (UDI 05051700018975)

Manufactured by The Binding Site Group Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Optilite® Anti-streptolysin O Control Pack - Primary ID 05051700018975

Device Regulatory Overview

The Optilite® Anti-streptolysin O Control Pack (Model/Catalog Number: NQ189.OPT) is a medical device manufactured by The Binding Site Group Ltd. This product is indexed under FDA Product Code / Category Classification W01021104 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
NQ189.OPT
Product Code / EMDN
W01021104
Device Name
Optilite® Anti-streptolysin O Kit
Database Sync Date
2026-08-09 17:11:32

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 Optilite® Anti-streptolysin O Control Pack?

The registered manufacturer of record for Optilite® Anti-streptolysin O Control Pack is The Binding Site Group Ltd.

What is the Primary UDI-DI identifier for Optilite® Anti-streptolysin O Control Pack?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 05051700018975.

What classification code is assigned to this device?

This device is registered under product classification code W01021104.

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