gudid Primary ID: DG-CKMB-6.5

JAS Diagnostics (UDI DG-CKMB-6.5)

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

Scannable UDI-DI Representation

Device Regulatory Overview

The JAS Diagnostics (Model/Catalog Number: DG-CKMB-6.5) is a medical device manufactured by DREW SCIENTIFIC, INC.. This product is indexed under FDA Product Code / Category Classification JHW within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: DG-CKMB-6.5
Product Code / EMDN: JHW
Device Name: CK MB ISOENZYME REAGENT (10x 6.5mL)
Database Sync Date: 2026-08-09 09:31:21

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 JAS Diagnostics?

The registered manufacturer of record for JAS Diagnostics is DREW SCIENTIFIC, INC..

What is the Primary UDI-DI identifier for JAS Diagnostics?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is DG-CKMB-6.5.

What classification code is assigned to this device?

This device is registered under product classification code JHW.

Similar Classification Devices (JHW)

Other Devices by DREW SCIENTIFIC, INC.

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