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ARCHITECT Homocysteine Controls - SFDA Registration ME0000002987SFDAA00141

Access comprehensive regulatory information for ARCHITECT Homocysteine Controls 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 ME0000002987SFDAA00141 and manufactured by Abbott GmbH. and 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)
ME0000002987SFDAA00141
ARCHITECT Homocysteine Controls
SFDA Registration: ME0000002987SFDAA00141
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Product Information

Controls quantitative determination of total L-homocysteine in human serum or plasma

Product Use

ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total L-homocysteine in human serum or plasma

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00141
Authorization ID
GHTF-2018-1102
Status
Active
Expire Date
April 02, 2021
Manufacturer
Manufacturer Name
Abbott GmbH. and Co. KG
Model Information
Model ID(s)
1L71-10
Product Accessories

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