eudamed_udi Primary ID: 06921756496548

Quik-Check 3D Hematology Reagent (Cyto-Lyser) (UDI 06921756496548)

Manufactured by Acon Biotech (Hangzhou) Co., Ltd.

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Quik-Check 3D Hematology Reagent (Cyto-Lyser) (Model/Catalog Number: C121-9027-201) is a medical device manufactured by Acon Biotech (Hangzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01030199 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0945-2022 View Full Alert →

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked...

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Technical Specifications

Model Number: C121-9027-201
Product Code / EMDN: W01030199
Device Name: 3D Hematology Reagent
Database Sync Date: 2026-08-09 16:28:47

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 Quik-Check 3D Hematology Reagent (Cyto-Lyser)?

The registered manufacturer of record for Quik-Check 3D Hematology Reagent (Cyto-Lyser) is Acon Biotech (Hangzhou) Co., Ltd..

What is the Primary UDI-DI identifier for Quik-Check 3D Hematology Reagent (Cyto-Lyser)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06921756496548.

What classification code is assigned to this device?

This device is registered under product classification code W01030199.

Similar Classification Devices (W01030199)

Other Devices by Acon Biotech (Hangzhou) Co., Ltd.

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