Saudi Arabia SFDA registration ME0000001481SFDAA00163
IMMULITE/IMMULITE 1000 systems CMV cmv IgG
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Limited·Annex II List BActiveProduct information
for the qualitative detection of IgG antibodies to Cytomegalovirus (CMV)in Human Serum
Product use
for invtro diagnostic use with the Immulte and immulite 1000 analyzers , for the qualitative detection of IgG antibodies to Cytomegalovirus (CMV)in human serum , as an aid in the determination of serological status to CMV .
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00163
- Authorization ID
- GHTF-2019-5843
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Limited
Model information
- Model ID(s)
- LKCV1
Product accessories
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About this record
Access comprehensive regulatory information for IMMULITE/IMMULITE 1000 systems CMV cmv IgG in the Saudi Arabia medical device market through Pure Global AI's free database. This Annex II List B device is registered with Saudi Arabia SFDA under registration number ME0000001481SFDAA00163 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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