GUDIDData
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pma Primary ID: P020027

FPSA FLEX REAGENT CARTRIDGE (UDI P020027)

Manufactured by Siemens Healthcare Diagnostics

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FPSA FLEX REAGENT CARTRIDGE - Primary ID P020027

Device Regulatory Overview

The FPSA FLEX REAGENT CARTRIDGE (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
Verify if facility inventory is affected by this recall.
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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 10:06:19

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 FPSA FLEX REAGENT CARTRIDGE?

The registered manufacturer of record for FPSA FLEX REAGENT CARTRIDGE is Siemens Healthcare Diagnostics.

What is the Primary UDI-DI identifier for FPSA FLEX REAGENT CARTRIDGE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P020027.

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

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

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