Saudi Arabia SFDA registration ME0000000973SFDAA00006
DxH 500 Lyse
Saudi Arabia·Chemicals·Beckman Coulter Ireland Inc.·General IVD(Others)ActiveProduct information
An agent for quantitative determination of hemoglobin and measurement of leukocytes
Product use
Erythrocyte lytic agent for quantitative determination of hemoglobin, and the counting, sizing and optical measurement of leukocytes on DxH 500 Systems. Use only with DxH 500 Diluent and DxH 500 Cleaner.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000000973SFDAA00006
- Authorization ID
- GHTF-2016-0494
- Status
- Active
- Expire Date
- April 09, 2019
Manufacturer
- Manufacturer Name
- Beckman Coulter Ireland Inc.
Model information
- Model ID(s)
- B36846
Product accessories
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About this record
Access comprehensive regulatory information for DxH 500 Lyse 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 ME0000000973SFDAA00006 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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