gudid Primary ID: 80-5383-00

Liquid Select Amylase Reagent (UDI 80-5383-00)

Manufactured by Sekisui Diagnostics, LLC

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Liquid Select Amylase Reagent (Model/Catalog Number: 80-5383-00) is a medical device manufactured by Sekisui Diagnostics, LLC. This product is indexed under FDA Product Code / Category Classification JFJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 80-5383-00
Product Code / EMDN: JFJ
Device Name
Database Sync Date: 2026-08-09 09:50:05

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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Frequently Asked Questions

Who is the primary manufacturer of Liquid Select Amylase Reagent?

The registered manufacturer of record for Liquid Select Amylase Reagent is Sekisui Diagnostics, LLC.

What is the Primary UDI-DI identifier for Liquid Select Amylase Reagent?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 80-5383-00.

What classification code is assigned to this device?

This device is registered under product classification code JFJ.

Similar Classification Devices (JFJ)

Other Devices by Sekisui Diagnostics, LLC

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