gudid
Primary ID: 1158864
VITROS (UDI 1158864)
Manufactured by ORTHO CLINICAL DIAGNOSTICS
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for VITROS - Primary ID 1158864
Device Regulatory Overview
The VITROS (Model/Catalog Number: 1158864) is a medical device manufactured by ORTHO CLINICAL DIAGNOSTICS. This product is indexed under FDA Product Code / Category Classification DBF within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1158864
- Product Code / EMDN
- DBF
- Device Name
- VITROS Immunodiagnostic Products Ferritin Calibrators
- Database Sync Date
- 2026-08-09 10:00:16
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 VITROS?
The registered manufacturer of record for VITROS is ORTHO CLINICAL DIAGNOSTICS.
What is the Primary UDI-DI identifier for VITROS?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 1158864.
What classification code is assigned to this device?
This device is registered under product classification code DBF.
Similar Classification Devices (DBF)
Other Devices by ORTHO CLINICAL DIAGNOSTICS
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