Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma) (UDI 06970581430630)
Manufactured by AccuBioTech Co., Ltd.
Device Regulatory Overview
The Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma) (Model/Catalog Number: ABT-IDT-B13) 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-B13
- Product Code / EMDN
- W0105090102
- Device Name
- Accu-Tell® H. pylori IgG Cassette
- Database Sync Date
- 2026-08-09 16:46:54
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 IgG Cassette (Whole Blood/Serum/Plasma)?
The registered manufacturer of record for Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma) is AccuBioTech Co., Ltd..
What is the Primary UDI-DI identifier for Accu-Tell®H. pylori IgG Cassette (Whole Blood/Serum/Plasma)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970581430630.
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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