Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) (UDI 06973315730518)
Manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.
Device Regulatory Overview
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) (Model/Catalog Number: C8611C) is a medical device manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.. This product is indexed under FDA Product Code / Category Classification W0105090501 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- C8611C
- Product Code / EMDN
- W0105090501
- Device Name
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)
- Database Sync Date
- 2026-08-09 16:51:16
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 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)?
The registered manufacturer of record for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) is Nanjing Vazyme Medical Technology Co.,Ltd..
What is the Primary UDI-DI identifier for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06973315730518.
What classification code is assigned to this device?
This device is registered under product classification code W0105090501.
Similar Classification Devices (W0105090501)
Other Devices by Nanjing Vazyme Medical Technology Co.,Ltd.
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