Saudi Arabia SFDA registration ME0000009057SFDAA00364

Chromsystems Internal Standard MassChrom® Methylmalonic Acid in urine

Saudi 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 urine

Product use

The internal standard set in Chromsystems reagent kit for determination of methylmalonic acid in urine is an in vitro diagnostic device to be used to compensate matrix effects to measure the concentration of methylmalonic acid in patient urine 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: ME0000009057SFDAA00364
Authorization ID: GHTF-2020-1378
Status: Active
Expire Date: June 24, 2023

Manufacturer

Manufacturer Name: Chromsystems Instruments&Chemicals GmbH

Model information

Model ID(s): 64044/U

Product accessories

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About this record

Access comprehensive regulatory information for Chromsystems Internal Standard MassChrom® Methylmalonic Acid in urine 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 ME0000009057SFDAA00364 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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