gudid
Primary ID: 0066827
TPHA Screen Diluent (UDI 0066827)
Manufactured by IMMUCOR, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for TPHA Screen Diluent - Primary ID 0066827
Device Regulatory Overview
The TPHA Screen Diluent (Model/Catalog Number: 0066827) is a medical device manufactured by IMMUCOR, INC.. This product is indexed under FDA Product Code / Category Classification MYR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 0066827
- Product Code / EMDN
- MYR
- Device Name
- TPHA Screen Diluent is a ready for use isotonic saline solution used to dilute sample plasma or serum, and control material, when testing with the TPHA Screen on an automated Blood Bank system. The product configuration is ten (10) vials.
- Database Sync Date
- 2026-08-09 09:39:01
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 TPHA Screen Diluent?
The registered manufacturer of record for TPHA Screen Diluent is IMMUCOR, INC..
What is the Primary UDI-DI identifier for TPHA Screen Diluent?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0066827.
What classification code is assigned to this device?
This device is registered under product classification code MYR.
Similar Classification Devices (MYR)
Other Devices by IMMUCOR, INC.
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