gudid
Primary ID: 88033
iScreen (UDI 88033)
Manufactured by BIOCHEMICAL DIAGNOSTICS INC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for iScreen - Primary ID 88033
Device Regulatory Overview
The iScreen (Model/Catalog Number: 88033) is a medical device manufactured by BIOCHEMICAL DIAGNOSTICS INC. This product is indexed under FDA Product Code / Category Classification DIF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 88033
- Product Code / EMDN
- DIF
- Device Name
- Alere Professional cup 2x10 mL kitbox
- Database Sync Date
- 2026-08-09 09:10:04
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 iScreen?
The registered manufacturer of record for iScreen is BIOCHEMICAL DIAGNOSTICS INC.
What is the Primary UDI-DI identifier for iScreen?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 88033.
What classification code is assigned to this device?
This device is registered under product classification code DIF.
Similar Classification Devices (DIF)
Other Devices by BIOCHEMICAL DIAGNOSTICS INC
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