Unspecified Brand (UDI 06974795550498)
Manufactured by RocGene (Xuzhou) Technology Limited
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: 10210121B) is a medical device manufactured by RocGene (Xuzhou) Technology Limited. This product is indexed under FDA Product Code / Category Classification W0105041106 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 10210121B
- Product Code / EMDN
- W0105041106
- Device Name
- SARS-CoV-2 Nucleic Acid Test Kit (PCR-Fluorescent Probe Method)
- Database Sync Date
- 2026-08-09 16:30:04
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 Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is RocGene (Xuzhou) Technology Limited.
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974795550498.
What classification code is assigned to this device?
This device is registered under product classification code W0105041106.
Similar Classification Devices (W0105041106)
Other Devices by RocGene (Xuzhou) Technology Limited
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