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DxH 500 Control - SFDA Registration ME0000000973SFDAA00009

Access comprehensive regulatory information for DxH 500 Control in the Saudi Arabia medical device market through Pure Global AI's free database. This General IVD(Others) device is registered with Saudi Arabia SFDA under registration number ME0000000973SFDAA00009 and manufactured by Beckman Coulter Ireland Inc..

This page provides complete registration details including product category (Chemicals), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.

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General IVD(Others)
ME0000000973SFDAA00009
DxH 500 Control
SFDA Registration: ME0000000973SFDAA00009
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Product Information

An assayed whole blood control to monitor values on multi parameter hematology cell counters

Product Use

DxH 500 Control is an assayed whole blood control designed to monitor values on multi parameter hematology cell counters. Refer to the Table of Expected Results for specific instrument models.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000000973SFDAA00009
Authorization ID
GHTF-2016-0494
Status
Active
Expire Date
April 09, 2019
Manufacturer
Model Information
Model ID(s)
B36872
Product Accessories

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