gudid
Primary ID: 403596
Positive Control (UDI 403596)
Manufactured by IMMUCOR GTI DIAGNOSTICS, INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Positive Control - Primary ID 403596
Device Regulatory Overview
The Positive Control (Model/Catalog Number: 403596) is a medical device manufactured by IMMUCOR GTI DIAGNOSTICS, INC.. This product is indexed under FDA Product Code / Category Classification GGP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 403596
- Product Code / EMDN
- GGP
- Device Name
- For Use with Factor VIII Antibody Screen
- 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 Positive Control?
The registered manufacturer of record for Positive Control is IMMUCOR GTI DIAGNOSTICS, INC..
What is the Primary UDI-DI identifier for Positive Control?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 403596.
What classification code is assigned to this device?
This device is registered under product classification code GGP.
Similar Classification Devices (GGP)
Other Devices by IMMUCOR GTI DIAGNOSTICS, INC.
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