ARCHITECT Free PSA (LN 6C07) (UDI P980007)
Manufactured by Abbott Laboratories
Device Regulatory Overview
The ARCHITECT Free PSA (LN 6C07) (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.
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 10:06:19
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 ARCHITECT Free PSA (LN 6C07)?
The registered manufacturer of record for ARCHITECT Free PSA (LN 6C07) is Abbott Laboratories.
What is the Primary UDI-DI identifier for ARCHITECT Free PSA (LN 6C07)?
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
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