Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (UDI 25 Tests/Kit)
Manufactured by Biohit Healthcare (Hefei) Co., Ltd.
Device Regulatory Overview
The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (Model/Catalog Number: 25 Tests/Kit) is a medical device manufactured by Biohit Healthcare (Hefei) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification QKO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 25 Tests/Kit
- Product Code / EMDN
- QKO
- Device Name
- Database Sync Date
- 2026-08-09 09:06:39
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 Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit?
The registered manufacturer of record for Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is Biohit Healthcare (Hefei) Co., Ltd..
What is the Primary UDI-DI identifier for Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 25 Tests/Kit.
What classification code is assigned to this device?
This device is registered under product classification code QKO.
Similar Classification Devices (QKO)
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