SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells (UDI 12525-300)
Manufactured by MONOBIND, INC.
Device Regulatory Overview
The SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells (Model/Catalog Number: 12525-300) is a medical device manufactured by MONOBIND, INC.. This product is indexed under FDA Product Code / Category Classification QKO within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 12525-300
- Product Code / EMDN
- QKO
- Device Name
- Database Sync Date
- 2026-08-09 09:31:26
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 SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells?
The registered manufacturer of record for SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells is MONOBIND, INC..
What is the Primary UDI-DI identifier for SARS-CoV-2 S1-RBD IgG AccuBind ELISA Test System - 192 Wells?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 12525-300.
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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