Accu-Tell®CK-MB Cassette (Whole Blood/Serum/Plasma) (UDI 06970581432030)
Manufactured by AccuBioTech Co., Ltd.
Device Regulatory Overview
The Accu-Tell®CK-MB Cassette (Whole Blood/Serum/Plasma) (Model/Catalog Number: ABT-CT-B66) is a medical device manufactured by AccuBioTech Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102160701 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- ABT-CT-B66
- Product Code / EMDN
- W0102160701
- Device Name
- Accu-Tell® CK-MB Test
- Database Sync Date
- 2026-08-09 16:48:20
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®CK-MB Cassette (Whole Blood/Serum/Plasma)?
The registered manufacturer of record for Accu-Tell®CK-MB Cassette (Whole Blood/Serum/Plasma) is AccuBioTech Co., Ltd..
What is the Primary UDI-DI identifier for Accu-Tell®CK-MB Cassette (Whole Blood/Serum/Plasma)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06970581432030.
What classification code is assigned to this device?
This device is registered under product classification code W0102160701.
Similar Classification Devices (W0102160701)
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