Pure Global

IMMULITEยฎ 2000 Systems ALB ALBUMIN - SFDA Registration ME0000001481SFDAA00389

Access comprehensive regulatory information for IMMULITEยฎ 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.

Free Database
Powered by Pure Global AI
SFDA Official Data
General IVD(Others)
ME0000001481SFDAA00389
IMMULITEยฎ 2000 Systems ALB ALBUMIN
SFDA Registration: ME0000001481SFDAA00389
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Information

assay for Detection and quantitation of microalbuminuria concentrations of albumin in urine

Product Use

For in vitro diagnostic use with the IMMULITEยฎย 2000 Systems Analyzers โ€” 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
Model Information
Model ID(s)
L2KHA2
Product Accessories

[]