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Abbott RealTime MTB Control Kit - SFDA Registration ME0000002987SFDAA00390

Access comprehensive regulatory information for Abbott RealTime MTB Control Kit 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 ME0000002987SFDAA00390 and manufactured by Abbott GmbH. & Co. KG.

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)
ME0000002987SFDAA00390
Abbott RealTime MTB Control Kit
SFDA Registration: ME0000002987SFDAA00390
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Product Information

Quality Control of MTB Assay

Product Use

The Abbott RealTime MTB Controls are used to establish run validity of the Abbott RealTime MTB assay when used for the qualitative detection of Mycobacterium tuberculosis (MTB) DNA in clinical specimens.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00390
Authorization ID
GHTF-2019-2944
Status
Active
Expire Date
August 05, 2022
Manufacturer
Manufacturer Name
Abbott GmbH. & Co. KG
Model Information
Model ID(s)
08N15-080
Product Accessories

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