gudid Primary ID: 37215

Access Hyritech free PSA Calibrators (UDI 37215)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Access Hyritech free PSA Calibrators (Model/Catalog Number: 37215) is a medical device manufactured by Beckman Coulter, Inc.. 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-1922-2026 View Full Alert →

Access Total T4 Calibrator, Catalog No. 33805...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

ID: Z-2115-2025 View Full Alert →

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

ID: Z-1794-2026 View Full Alert →

MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative ...

🔒 Compromised Lot & Serial Numbers Locked

Verify if facility inventory is affected by this recall.

Unlock Lot Data ($49)

Technical Specifications

Model Number: 37215
Product Code / EMDN: MTG
Device Name: The Access Hybritech free PSA Calibrators are intended to calibrate the Access Hybritech free PSA assay for the quantitative determination of free PSA levels in human serum using the Access Immunoassay Systems.
Database Sync Date: 2026-08-09 09:41:49

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 Access Hyritech free PSA Calibrators?

The registered manufacturer of record for Access Hyritech free PSA Calibrators is Beckman Coulter, Inc..

What is the Primary UDI-DI identifier for Access Hyritech free PSA Calibrators?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 37215.

What classification code is assigned to this device?

This device is registered under product classification code MTG.

Similar Classification Devices (MTG)

Other Devices by Beckman Coulter, Inc.

Programmatic Export

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

JSON API Endpoint