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IMMULITEยฎ 2000 Systems CMB CK-MB - SFDA Registration ME0000001481SFDAA00401

Access comprehensive regulatory information for IMMULITEยฎ 2000 Systems CMB CK-MB 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 ME0000001481SFDAA00401 and manufactured by Siemens Healthcare diagnostics products Limited.

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)
ME0000001481SFDAA00401
IMMULITEยฎ 2000 Systems CMB CK-MB
SFDA Registration: ME0000001481SFDAA00401
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Product Information

assay for Quantitative measurement of creatine kinase isoenzyme in heparinized plasma or serum

Product Use

For in vitro diagnostic use with the IMMULITEยฎย 2000 Systems Analyzers โ€” for the quantitative measurement of creatine kinase isoenzyme MB (CK-MB) in heparinized plasma or serum, as an aid in patient management and the assessment of prognosis of myocardial infarction.

Device Classification
Risk Class
General IVD(Others)
Product Category
Chemicals
Product Type
IVD
Registration Information
Registration ID
ME0000001481SFDAA00401
Authorization ID
GHTF-2016-1236
Status
Active
Expire Date
August 05, 2019
Model Information
Model ID(s)
L2KMB2
Product Accessories

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