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pma Primary ID: P950021

Atelica IM Prostate-Specific Antigen (PSA) (UDI P950021)

Manufactured by Siemens Healthcare Diagnostics

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Atelica IM Prostate-Specific Antigen (PSA) - Primary ID P950021

Device Regulatory Overview

The Atelica IM Prostate-Specific Antigen (PSA) (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics. This product is indexed under FDA Product Code / Category Classification MTG within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-0343-2014 View Full Alert →

ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measu...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0648-2013 View Full Alert →

Immunoradiometric assay. Device is an immunoradiometric assay designed for the quantitative measurement of thyroid stimulating hormone (t...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-0122-2015 View Full Alert →

IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE ...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

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 10:06:17

Full Regulatory Attributes

🔒 Token Gated 
{
    "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 Atelica IM Prostate-Specific Antigen (PSA)?

The registered manufacturer of record for Atelica IM Prostate-Specific Antigen (PSA) is Siemens Healthcare Diagnostics.

What is the Primary UDI-DI identifier for Atelica IM Prostate-Specific Antigen (PSA)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P950021.

What classification code is assigned to this device?

This device is registered under product classification code MTG.

Similar Classification Devices (MTG)

Other Devices by Siemens Healthcare Diagnostics

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