Saudi Arabia SFDA registration ME0000000973SFDAA00024
iQ® Calibrator Pack
Saudi Arabia·Chemicals·Beckman Coulter Ireland Inc.·General IVD(Others)ActiveProduct information
Reagent for the calibration of Automated Urine Microscopy Analyzer
Product use
iQ Calibrator is a suspension of fixed human red blood cells in a particulate-free solution. It is used to automatically calibrate the iQ200 Series Automated Urine Microscopy Analyzer. An accurate count is certified and the expected value (accurate to approximately 8.3%) is printed on each label.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000000973SFDAA00024
- Authorization ID
- GHTF-2019-0913
- Status
- Active
- Expire Date
- April 04, 2020
Manufacturer
- Manufacturer Name
- Beckman Coulter Ireland Inc.
Model information
- Model ID(s)
- 800-3103
Product accessories
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About this record
Access comprehensive regulatory information for iQ® Calibrator Pack 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 ME0000000973SFDAA00024 and manufactured by Beckman Coulter Ireland 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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