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Atellica IM EHIV QC - SFDA Registration ME0000001435SFDAA01318

Access comprehensive regulatory information for Atellica IM EHIV QC in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List A device is registered with Saudi Arabia SFDA under registration number ME0000001435SFDAA01318 and manufactured by Siemens Healthcare diagnostics 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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Annex II List A
ME0000001435SFDAA01318
Atellica IM EHIV QC
SFDA Registration: ME0000001435SFDAA01318
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Product Information

Quality control for human immunodeficiency virus assay

Product Use

The Atellicaโ„ข IM HIV 1/O/2 Enhanced Quality Control (EHIV QC) is for in vitro diagnostic use in monitoring the performance of the Atellica IM EHIV assay using the Atellicaโ„ข IM Analyzer.

Device Classification
Risk Class
Annex II List A
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001435SFDAA01318
Authorization ID
GHTF-2019-0422
Status
Active
Expire Date
December 31, 2019
Manufacturer
Model Information
Model ID(s)
10995612
Product Accessories

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