ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (UDI P000027)
Manufactured by Roche Diagnostics Corp.
Device Regulatory Overview
The ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER (Model/Catalog Number: Unspecified) is a medical device manufactured by Roche Diagnostics Corp.. This product is indexed under FDA Product Code / Category Classification MTG within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- MTG
- Device Name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Database Sync Date
- 2026-08-09 10:04:45
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER?
The registered manufacturer of record for ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER is Roche Diagnostics Corp..
What is the Primary UDI-DI identifier for ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P000027.
What classification code is assigned to this device?
This device is registered under product classification code MTG.
Similar Classification Devices (MTG)
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint