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Abbott RealTime MTB RIF/INH Resistance Control Kit - SFDA Registration ME0000002987SFDAA00392

Access comprehensive regulatory information for Abbott RealTime MTB RIF/INH Resistance 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 ME0000002987SFDAA00392 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)
ME0000002987SFDAA00392
Abbott RealTime MTB RIF/INH Resistance Control Kit
SFDA Registration: ME0000002987SFDAA00392
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Product Information

Quality control for MTB RIF/INH Resistance

Product Use

Control Kit is used to establish run validity of the Abbott RealTime MTB RIF/INH Resistance assay when used for the qualitative detection of Rifampicin (RIF) and Isoniazid (INH) resistance in Mycobacterium tuberculosis (MTB) positive samples.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00392
Authorization ID
GHTF-2019-2944
Status
Active
Expire Date
August 05, 2022
Manufacturer
Manufacturer Name
Abbott GmbH. & Co. KG
Model Information
Model ID(s)
08N28-080
Product Accessories

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