GUDIDData
Bulk Audit Tool API Access
pma Primary ID: P930027

PSA IMMULITE ASSAY (UDI P930027)

Manufactured by Siemens Healthcare Diagnostics, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PSA IMMULITE ASSAY - Primary ID P930027

Device Regulatory Overview

The PSA IMMULITE ASSAY (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. This product is indexed under FDA Product Code / Category Classification MTF 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-2703-2026 View Full Alert →

Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2398-2026 View Full Alert →

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1980-2026 View Full Alert →

Dimension Creatinine Flex reagent cartridge. Material Number: 10872079....

🔒 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
MTF
Device Name
Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Database Sync Date
2026-08-09 10:06:14

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 PSA IMMULITE ASSAY?

The registered manufacturer of record for PSA IMMULITE ASSAY is Siemens Healthcare Diagnostics, Inc..

What is the Primary UDI-DI identifier for PSA IMMULITE ASSAY?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P930027.

What classification code is assigned to this device?

This device is registered under product classification code MTF.

Similar Classification Devices (MTF)

Other Devices by Siemens Healthcare Diagnostics, Inc.

Programmatic Export

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

JSON API Endpoint