Unspecified Brand (UDI 10845357042191)
Manufactured by Microbiologics, INC.
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: [HE0045N] Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG)) is a medical device manufactured by Microbiologics, INC.. This product is indexed under FDA Product Code / Category Classification W0105080801 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- [HE0045N] Helix Elite™ Molecular Standards Inactivated Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG)
- Product Code / EMDN
- W0105080801
- Device Name
- Helix Elite™ Molecular Standards: Inactivated Standard
- Database Sync Date
- 2026-08-09 16:29:07
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 Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is Microbiologics, INC..
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 10845357042191.
What classification code is assigned to this device?
This device is registered under product classification code W0105080801.
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