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ARCHITECT Homocysteine Calibrators - SFDA Registration ME0000002987SFDAA00140

Access comprehensive regulatory information for ARCHITECT Homocysteine Calibrators 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 ME0000002987SFDAA00140 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)
ME0000002987SFDAA00140
ARCHITECT Homocysteine Calibrators
SFDA Registration: ME0000002987SFDAA00140
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Product Information

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

Product Use

ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total L-homocysteine in human serum or plasma. Refer to the ARCHITECT Homocysteine reagent package insert and the ARCHITECT System Operations Manual for additional information.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00140
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)
1L71-01
Product Accessories

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