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ARCHITECT PIVKA-II Calibrators - SFDA Registration ME0000002987SFDAA00031

Access comprehensive regulatory information for ARCHITECT PIVKA-II 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 ME0000002987SFDAA00031 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)
ME0000002987SFDAA00031
ARCHITECT PIVKA-II Calibrators
SFDA Registration: ME0000002987SFDAA00031
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Product Information

Calibrator For the quantitative determination of PIVKA-II

Product Use

The ARCHITECT PIVKA-II Calibrators are for the calibration 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
ME0000002987SFDAA00031
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)
2P48-01
Product Accessories

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