pma Primary ID: P060005

IMMULITE / IMMULITE 1000 FREE PSA (UDI P060005)

Manufactured by Siemens Medical Solutions Diagnostics Limited

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The IMMULITE / IMMULITE 1000 FREE PSA (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Medical Solutions Diagnostics Limited. 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 10:06:22

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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Frequently Asked Questions

Who is the primary manufacturer of IMMULITE / IMMULITE 1000 FREE PSA?

The registered manufacturer of record for IMMULITE / IMMULITE 1000 FREE PSA is Siemens Medical Solutions Diagnostics Limited.

What is the Primary UDI-DI identifier for IMMULITE / IMMULITE 1000 FREE PSA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P060005.

What classification code is assigned to this device?

This device is registered under product classification code MTG.

Similar Classification Devices (MTG)

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