Lp-PLA2 STAT (eCLIA) (UDI 06978139078273)
Manufactured by Shenzhen Lifotronic Technology Co., Ltd.
Device Regulatory Overview
The Lp-PLA2 STAT (eCLIA) (Model/Catalog Number: 0320511504) is a medical device manufactured by Shenzhen Lifotronic Technology Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W01021312 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 0320511504
- Product Code / EMDN
- W01021312
- Device Name
- Lp-PLA2 STAT (eCLIA)
- Database Sync Date
- 2026-08-09 18:19:14
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 Lp-PLA2 STAT (eCLIA)?
The registered manufacturer of record for Lp-PLA2 STAT (eCLIA) is Shenzhen Lifotronic Technology Co., Ltd..
What is the Primary UDI-DI identifier for Lp-PLA2 STAT (eCLIA)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06978139078273.
What classification code is assigned to this device?
This device is registered under product classification code W01021312.
Similar Classification Devices (W01021312)
Other Devices by Shenzhen Lifotronic Technology Co., Ltd.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint