Saudi Arabia SFDA registration ME0000001435SFDAA01305
Atellica IM FBHCG
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics Inc·Annex II List BActiveProduct information
ivd use in the quantitative determination of free beta of chorionic gonadotropin in human serum
Product use
"The Atellica® IM Free Beta Human Chorionic Gonadotropin (FBHCG) assay is for in vitro
diagnostic use in the quantitative determination of the free beta subunit of chorionic
gonadotropin in human serum using the Atellica® IM Analyzer.
The Atellica IM FBHCG assay is intended for use as one component in combination with other
parameters to evaluate the risk of Trisomy 21 (Down syndrome) during the first trimester of
pregnancy. Further testing is required for diagnosis of chromosomal aberrations"
Device classification
- Risk Class
- Annex II List B
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001435SFDAA01305
- Authorization ID
- GHTF-2019-0418
- Status
- Active
- Expire Date
- December 31, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics Inc
Model information
- Model ID(s)
- 10733009, 10733010
Product accessories
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About this record
Access comprehensive regulatory information for Atellica IM FBHCG 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 ME0000001435SFDAA01305 and manufactured by Siemens Healthcare diagnostics Inc.
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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