Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing) (UDI 06974081870361)
Manufactured by SINGUWAY BIOTECH INC.
Device Regulatory Overview
The Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing) (Model/Catalog Number: TB001-48) is a medical device manufactured by SINGUWAY BIOTECH INC.. This product is indexed under FDA Product Code / Category Classification W0105010703 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- TB001-48
- Product Code / EMDN
- W0105010703
- Device Name
- Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)
- Database Sync Date
- 2026-08-09 18:54:07
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 Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)?
The registered manufacturer of record for Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing) is SINGUWAY BIOTECH INC..
What is the Primary UDI-DI identifier for Detection Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence Probing)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974081870361.
What classification code is assigned to this device?
This device is registered under product classification code W0105010703.
Similar Classification Devices (W0105010703)
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