Saudi Arabia SFDA registration ME0000001481SFDAA00401
IMMULITE® 2000 Systems CMB CK-MB
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Limited·General IVD(Others)ActiveProduct information
assay for Quantitative measurement of creatine kinase isoenzyme in heparinized plasma or serum
Product use
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — 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
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Limited
Model information
- Model ID(s)
- L2KMB2
Product accessories
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About this record
Access comprehensive regulatory information for IMMULITE® 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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