GenomEra® MRSA/SA Multi Swab Assay Kit (UDI D-CDX-30-02-20TK)
Manufactured by Abacus Diagnostica Oy
Device Regulatory Overview
The GenomEra® MRSA/SA Multi Swab Assay Kit (Model/Catalog Number: CDX-30-02-20) is a medical device manufactured by Abacus Diagnostica Oy. This product is indexed under FDA Product Code / Category Classification W0105011203 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- CDX-30-02-20
- Product Code / EMDN
- W0105011203
- Device Name
- CDX-30-02
- Database Sync Date
- 2026-08-09 18:31:10
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 GenomEra® MRSA/SA Multi Swab Assay Kit?
The registered manufacturer of record for GenomEra® MRSA/SA Multi Swab Assay Kit is Abacus Diagnostica Oy.
What is the Primary UDI-DI identifier for GenomEra® MRSA/SA Multi Swab Assay Kit?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-CDX-30-02-20TK.
What classification code is assigned to this device?
This device is registered under product classification code W0105011203.
Similar Classification Devices (W0105011203)
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