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ARCHITECT PIVKA-II Controls - SFDA Registration ME0000002987SFDAA00029

Access comprehensive regulatory information for ARCHITECT PIVKA-II 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 ME0000002987SFDAA00029 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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SFDA Official Data
General IVD(Others)
ME0000002987SFDAA00029
ARCHITECT PIVKA-II Controls
SFDA Registration: ME0000002987SFDAA00029
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Product Information

Controls for the quantitative determination of PIVKA-II

Product Use

The ARCHITECT PIVKA-II Controls are for the verification of the accuracy and precision of the ARCHITECT iSystem when used for the quantitative determination of PIVKA-II in human serum and plasma.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000002987SFDAA00029
Authorization ID
GHTF-2019-6138
Status
Active
Expire Date
February 10, 2021
Manufacturer
Manufacturer Name
Abbott GmbH. and Co. KG
Model Information
Model ID(s)
2P48-10
Product Accessories

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