CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) (UDI 06954414792638)
Manufactured by Getein Biotech, Inc.
Device Regulatory Overview
The CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) (Model/Catalog Number: IF1005、IF2005、 IF3005、IF4005、 IF5005、 IF6005、 IF8005) is a medical device manufactured by Getein Biotech, Inc.. This product is indexed under FDA Product Code / Category Classification W01021399 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- IF1005、IF2005、 IF3005、IF4005、 IF5005、 IF6005、 IF8005
- Product Code / EMDN
- W01021399
- Device Name
- CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)
- Database Sync Date
- 2026-08-09 16:50:43
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 CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)?
The registered manufacturer of record for CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay) is Getein Biotech, Inc..
What is the Primary UDI-DI identifier for CK-MB/cTnI/Myo Fast Test Kit (Immunofluorescence Assay)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06954414792638.
What classification code is assigned to this device?
This device is registered under product classification code W01021399.
Similar Classification Devices (W01021399)
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