eudamed_udi Primary ID: D-77405JA

SPOTCHEM II GPT/ALT (UDI D-77405JA)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The SPOTCHEM II GPT/ALT (Model/Catalog Number: 77405) is a medical device manufactured by ARKRAY Factory, Inc.. This product is indexed under FDA Product Code / Category Classification W01010103 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 77405
Product Code / EMDN: W01010103
Device Name: SPOTCHEM II GPT/ALT
Database Sync Date: 2026-08-09 16:47:00

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 SPOTCHEM II GPT/ALT?

The registered manufacturer of record for SPOTCHEM II GPT/ALT is ARKRAY Factory, Inc..

What is the Primary UDI-DI identifier for SPOTCHEM II GPT/ALT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is D-77405JA.

What classification code is assigned to this device?

This device is registered under product classification code W01010103.

Similar Classification Devices (W01010103)

Other Devices by ARKRAY Factory, Inc.

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