GUDIDData
eudamed_udi Primary ID: 06942028501609

Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) (UDI 06942028501609)

Manufactured by Sichuan Orienter Biotechnology Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) - Primary ID 06942028501609

Device Regulatory Overview

The Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) (Model/Catalog Number: DG0601) is a medical device manufactured by Sichuan Orienter Biotechnology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0103020502 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
DG0601
Product Code / EMDN
W0103020502
Device Name
Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay)
Database Sync Date
2026-08-09 16:50:40

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 Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay)?

The registered manufacturer of record for Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay) is Sichuan Orienter Biotechnology Co., Ltd..

What is the Primary UDI-DI identifier for Fibrin Degradation Products (FDP) Assay Kit (Chemiluminescent Immunoassay)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06942028501609.

What classification code is assigned to this device?

This device is registered under product classification code W0103020502.

Programmatic Export

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

JSON API Endpoint