GUDIDData
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pma Primary ID: P980007

ARCHITECT Free PSA / Alinity i Free PSA (UDI P980007)

Manufactured by Abbott Laboratories

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ARCHITECT Free PSA / Alinity i Free PSA - Primary ID P980007

Device Regulatory Overview

The ARCHITECT Free PSA / Alinity i Free PSA (Model/Catalog Number: Unspecified) is a medical device manufactured by Abbott Laboratories. 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-0961-2026 View Full Alert →

Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1652-2025 View Full Alert →

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product Des...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-1654-2025 View Full Alert →

Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Version: All software versions Product Des...

🔒 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 10:04:44

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 ARCHITECT Free PSA / Alinity i Free PSA?

The registered manufacturer of record for ARCHITECT Free PSA / Alinity i Free PSA is Abbott Laboratories.

What is the Primary UDI-DI identifier for ARCHITECT Free PSA / Alinity i Free PSA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P980007.

What classification code is assigned to this device?

This device is registered under product classification code MTG.

Similar Classification Devices (MTG)

Other Devices by Abbott Laboratories

Programmatic Export

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