Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) (UDI 06974081870378)
Manufactured by SINGUWAY BIOTECH INC.
Device Regulatory Overview
The Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) (Model/Catalog Number: HPV002-48) is a medical device manufactured by SINGUWAY BIOTECH INC.. This product is indexed under FDA Product Code / Category Classification W0105041002 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HPV002-48
- Product Code / EMDN
- W0105041002
- Device Name
- Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing)
- Database Sync Date
- 2026-08-09 19:05:21
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 Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing)?
The registered manufacturer of record for Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) is SINGUWAY BIOTECH INC..
What is the Primary UDI-DI identifier for Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974081870378.
What classification code is assigned to this device?
This device is registered under product classification code W0105041002.
Similar Classification Devices (W0105041002)
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