Access Hybritech free PSA (UDI P970038)
Manufactured by Beckman Coulter, Inc.
Device Regulatory Overview
The Access Hybritech free PSA (Model/Catalog Number: Unspecified) 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.
Enforcement actions are currently active for this product line.
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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 10:06:14
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Access Hybritech free PSA?
The registered manufacturer of record for Access Hybritech free PSA is Beckman Coulter, Inc..
What is the Primary UDI-DI identifier for Access Hybritech free PSA?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is P970038.
What classification code is assigned to this device?
This device is registered under product classification code MTG.
Similar Classification Devices (MTG)
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