Saudi Arabia SFDA registration ME0000001481SFDAA00389
IMMULITE® 2000 Systems ALB ALBUMIN
Saudi Arabia·Chemicals·Siemens Healthcare diagnostics products Limited·General IVD(Others)ActiveProduct information
assay for Detection and quantitation of microalbuminuria concentrations of albumin in urine
Product use
For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers — for the detection and quantitation of microalbuminuria, that is, concentrations of albumin in human urine not detectable by conventional dipstick methods. It is intended for use as an aid in monitoring the development of incipient diabetic nephropathy.
Device classification
- Risk Class
- General IVD(Others)
- Product Category
- Chemicals
- Product Type
- IVD
Registration information
- Registration ID
- ME0000001481SFDAA00389
- Authorization ID
- GHTF-2016-1236
- Status
- Active
- Expire Date
- August 05, 2019
Manufacturer
- Manufacturer Name
- Siemens Healthcare diagnostics products Limited
Model information
- Model ID(s)
- L2KHA2
Product accessories
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About this record
Access comprehensive regulatory information for IMMULITE® 2000 Systems ALB ALBUMIN 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 ME0000001481SFDAA00389 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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