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Saudi Arabia SFDA registration ME0000009057SFDAA00361

Chromsystems Internal Standard MassChrom® Methylmalonic Acid in plasma/serum

Saudi Arabia flagSaudi Arabia·Chemicals·Chromsystems Instruments&Chemicals GmbH·General IVD(Others)Active
Product information
Internal standard set with isotopic labelled analytes used to quantify methylmalonic acid in plasma or serum
Product use
The internal standard set in Chromsystems reagent kit for determination of methylmalonic acid in plasma/serum is an in vitro diagnostic device to be used to compensate matrix effects to measure the concentration of methylmalonic acid in patient plasma or serum samples via high performance liquid chromatography with MS-detection (LC-MS/MS).
Device classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration information
Registration ID
ME0000009057SFDAA00361
Authorization ID
GHTF-2020-1378
Status
Active
Expire Date
June 24, 2023
Manufacturer
Manufacturer Name
Chromsystems Instruments&Chemicals GmbH
Model information
Model ID(s)
64004/P
Product accessories
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About this record

Access comprehensive regulatory information for Chromsystems Internal Standard MassChrom® Methylmalonic Acid in plasma/serum 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 ME0000009057SFDAA00361 and manufactured by Chromsystems Instruments&Chemicals GmbH.

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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