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ARCHITECT Homocystine Reagent Kit - SFDA Registration ME0000002987SFDAA00148

Access comprehensive regulatory information for ARCHITECT Homocystine Reagent 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 ME0000002987SFDAA00148 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)
ME0000002987SFDAA00148
ARCHITECT Homocystine Reagent Kit
SFDA Registration: ME0000002987SFDAA00148
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Product Information

Reagent for quantitative determination of total Lโ€‘homocysteine in human serum or plasma

Product Use

ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total Lโ€‘homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00148
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)
1L71-20,1L71-25,
Product Accessories

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