ARCHITECT (UDI 1E49-21)
Manufactured by Abbott GmbH
Device Regulatory Overview
The ARCHITECT (Model/Catalog Number: 1E49-21) is a medical device manufactured by Abbott GmbH. This product is indexed under FDA Product Code / Category Classification CGZ within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35...
Alinity i Anti-HCV Reagent Kit, List Number 08P0521...
Technical Specifications
- Model Number
- 1E49-21
- Product Code / EMDN
- CGZ
- Device Name
- ICT Reference Solution
- Database Sync Date
- 2026-08-09 10:02:49
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 ARCHITECT?
The registered manufacturer of record for ARCHITECT is Abbott GmbH.
What is the Primary UDI-DI identifier for ARCHITECT?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1E49-21.
What classification code is assigned to this device?
This device is registered under product classification code CGZ.
Similar Classification Devices (CGZ)
Other Devices by Abbott GmbH
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