GUDIDData
eudamed_udi Primary ID: 00816085024110

QC1™ Malaria Slides (UDI 00816085024110)

Manufactured by CalibreScientific US, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for QC1™ Malaria Slides - Primary ID 00816085024110

Device Regulatory Overview

The QC1™ Malaria Slides (Model/Catalog Number: 0003267) is a medical device manufactured by CalibreScientific US, Inc.. This product is indexed under FDA Product Code / Category Classification W01040699 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
0003267
Product Code / EMDN
W01040699
Device Name
QC1 Quality Control Slides
Database Sync Date
2026-08-09 17:15:02

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 QC1™ Malaria Slides?

The registered manufacturer of record for QC1™ Malaria Slides is CalibreScientific US, Inc..

What is the Primary UDI-DI identifier for QC1™ Malaria Slides?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816085024110.

What classification code is assigned to this device?

This device is registered under product classification code W01040699.

Programmatic Export

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

JSON API Endpoint