Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe) (UDI 06974081870057)
Manufactured by SINGUWAY BIOTECH INC.
Device Regulatory Overview
The Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe) (Model/Catalog Number: PCR001) is a medical device manufactured by SINGUWAY BIOTECH INC.. This product is indexed under FDA Product Code / Category Classification W0105041106 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- PCR001
- Product Code / EMDN
- W0105041106
- Device Name
- Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)
- Database Sync Date
- 2026-08-09 18:03:07
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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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)?
The registered manufacturer of record for Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe) is SINGUWAY BIOTECH INC..
What is the Primary UDI-DI identifier for Detection Kit For Coronavirus Disease 2019 (COVID-19) (PCR Fluorescence Probe)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974081870057.
What classification code is assigned to this device?
This device is registered under product classification code W0105041106.
Similar Classification Devices (W0105041106)
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