Saudi Arabia SFDA registration ME0000002988SFDAA00030
ARCHITECT Total β-hCG Controls
Saudi Arabia·Chemicals·Abbott Ireland Diagnostics Division·General IVD(Others)ActiveProduct information
Quality control for Total b-hCG
Product use
ARCHITECT Total b-hCG Controls are for the use in quality control to
monitor the accuracy and precision of the ARCHITECT Total b-hCG assay
system in human serum or plasma.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000002988SFDAA00030
- Authorization ID
- GHTF-2016-0821
- Status
- Active
- Expire Date
- March 27, 2019
Manufacturer
- Manufacturer Name
- Abbott Ireland Diagnostics Division
Model information
- Model ID(s)
- 7K78-10
Product accessories
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About this record
Access comprehensive regulatory information for ARCHITECT Total β-hCG Controls 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 ME0000002988SFDAA00030 and manufactured by Abbott Ireland Diagnostics Division.
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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