Saudi Arabia SFDA registration ME0000001481SFDAA00161
IMMULITE/IMMULITE 1000 Systems CMM CMV IgM
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Limited·Annex II List BActiveProduct information
For the Qualitative Detection of
IgM Antibodies to Cytomegalovirus (CMV)
in Human Serum and Plasma
Product use
For in vitro diagnostic use
with the IMMULITE and IMMULITE 1000
Analyzers — for the qualitative detection
of IgM antibodies to cytomegalovirus
(CMV) in human serum or plasma (EDTA
or heparinized), as an aid in the diagnosis
of current and recent CMV infection in
individuals with signs and symptoms of
CMV infection or clinical suspicion of CMV
infection. This assay is not FDA cleared or
approved for use in testing (screening)
blood or plasma donors, neonatal
screening, or for use at point-of-care
facilities
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00161
- 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)
- LKCM1
Product accessories
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About this record
Access comprehensive regulatory information for IMMULITE/IMMULITE 1000 Systems CMM CMV IgM 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 ME0000001481SFDAA00161 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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