gudid
Primary ID: LCSAB101
VisuCon-L Coag Screen ABN1 Plasma (UDI LCSAB101)
Manufactured by Affinity Biologicals Inc
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for VisuCon-L Coag Screen ABN1 Plasma - Primary ID LCSAB101
Device Regulatory Overview
The VisuCon-L Coag Screen ABN1 Plasma (Model/Catalog Number: LCSAB101) is a medical device manufactured by Affinity Biologicals Inc. This product is indexed under FDA Product Code / Category Classification GGN within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- LCSAB101
- Product Code / EMDN
- GGN
- Device Name
- A pool of citrated human plasma collected from a minimum of 20 donors that has been depleted of specific clotting factors. The plasma is buffered with 0.05M HEPES buffer and stabilizers, dispensed, and lyophilized. This plasma is used for the quality control of coagulation assays (PT and APTT) in the mid-level abnormal range.
- Database Sync Date
- 2026-08-09 09:37:15
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 VisuCon-L Coag Screen ABN1 Plasma?
The registered manufacturer of record for VisuCon-L Coag Screen ABN1 Plasma is Affinity Biologicals Inc.
What is the Primary UDI-DI identifier for VisuCon-L Coag Screen ABN1 Plasma?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is LCSAB101.
What classification code is assigned to this device?
This device is registered under product classification code GGN.
Similar Classification Devices (GGN)
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