SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva (UDI 06974849366501)
Manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Device Regulatory Overview
The SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva (Model/Catalog Number: HWTS-RT062E) is a medical device manufactured by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105099099 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- HWTS-RT062E
- Product Code / EMDN
- W0105099099
- Device Name
- SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva
- Database Sync Date
- 2026-08-09 16:29:13
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva?
The registered manufacturer of record for SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva is Jiangsu Macro & Micro-Test Med-Tech Co., Ltd..
What is the Primary UDI-DI identifier for SARS-CoV-2 Virus Antigen Detection Kit (colloidal gold method)-Saliva?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06974849366501.
What classification code is assigned to this device?
This device is registered under product classification code W0105099099.
Similar Classification Devices (W0105099099)
Other Devices by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint