GUDIDData
eudamed_udi Primary ID: 06974849366266

SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) (UDI 06974849366266)

Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) - Primary ID 06974849366266

Device Regulatory Overview

The SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) (Model/Catalog Number: HWTS-RT060A) is a medical device manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105900102 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
HWTS-RT060A
Product Code / EMDN
W0105900102
Device Name
SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)
Database Sync Date
2026-08-09 16:46:38

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 SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)?

The registered manufacturer of record for SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR) is Jiangsu Macro & Micro-Test Med-Tech Co., Ltd..

What is the Primary UDI-DI identifier for SARS-CoV-2/influenza A /influenza B Nucleic Acid Combined Detection Kit (Fluorescence PCR)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974849366266.

What classification code is assigned to this device?

This device is registered under product classification code W0105900102.

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