gudid Primary ID: GEN-AMY

GENCHEM Amylase Reagent (UDI GEN-AMY)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The GENCHEM Amylase Reagent (Model/Catalog Number: GEN-AMY) is a medical device manufactured by GENCHEM INC. This product is indexed under FDA Product Code / Category Classification JFJ within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: GEN-AMY
Product Code / EMDN: JFJ
Device Name: 10/17/2022
Database Sync Date: 2026-08-09 09:49:36

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 GENCHEM Amylase Reagent?

The registered manufacturer of record for GENCHEM Amylase Reagent is GENCHEM INC.

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

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GEN-AMY.

What classification code is assigned to this device?

This device is registered under product classification code JFJ.

Similar Classification Devices (JFJ)

Other Devices by GENCHEM INC

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint