Accu-Tell® H. pylori Antigen Cassette (Feces) (UDI 06970581430487)
Manufactured by AccuBioTech Co., Ltd.
Device Regulatory Overview
The Accu-Tell® H. pylori Antigen Cassette (Feces) (Model/Catalog Number: ABT-IDT-B76) is a medical device manufactured by AccuBioTech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0105090102 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ABT-IDT-B76
- Product Code / EMDN
- W0105090102
- Device Name
- Accu-Tell® Rapid H. pylori Antigen Test
- Database Sync Date
- 2026-08-09 16:48:01
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 Accu-Tell® H. pylori Antigen Cassette (Feces)?
The registered manufacturer of record for Accu-Tell® H. pylori Antigen Cassette (Feces) is AccuBioTech Co., Ltd..
What is the Primary UDI-DI identifier for Accu-Tell® H. pylori Antigen Cassette (Feces)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970581430487.
What classification code is assigned to this device?
This device is registered under product classification code W0105090102.
Similar Classification Devices (W0105090102)
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