gudid
Primary ID: 0002227
Checkcell (Weak) (UDI 0002227)
Manufactured by IMMUCOR, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Checkcell (Weak) - Primary ID 0002227
Device Regulatory Overview
The Checkcell (Weak) (Model/Catalog Number: 0002227) is a medical device manufactured by IMMUCOR, INC.. This product is indexed under FDA Product Code / Category Classification KSF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 0002227
- Product Code / EMDN
- KSF
- Device Name
- Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
- Database Sync Date
- 2026-08-09 09:39:02
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 Checkcell (Weak)?
The registered manufacturer of record for Checkcell (Weak) is IMMUCOR, INC..
What is the Primary UDI-DI identifier for Checkcell (Weak)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0002227.
What classification code is assigned to this device?
This device is registered under product classification code KSF.
Similar Classification Devices (KSF)
Other Devices by IMMUCOR, INC.
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