Quality Control - India CDSCO Medical Device Registration
Quality Control is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000122_2b68a2bf3641ac89e02bb903f3e4af4d_0ed7c0b9754216000fefa81ae6c3f926. This device is marketed under the brand name EDAN HL600 Lyse. The license holder is Medispace Solutions, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
EDAN HL600 Lyse
License Holder
Medispace SolutionsDevice Class
Approving Authority
CDSCO
Product Information
ED-30D Hematology Control is designed to monitor values on H30 Hematology Analyzer to ensure the analyzer’s performance before patient’s sample tests
Diluent
Brand: EDAN HL600 Lyse
Medispace Solutions
Diluent
Brand: EDAN HL600 Lyse
Medispace Solutions
Cleaner
Brand: EDAN HL600 Lyse
Medispace Solutions
Calibrator
Brand: EDAN HL600 Lyse
Medispace Solutions
Lyse
Brand: EDAN HL600 Lyse
Medispace Solutions
Lyse
Brand: EDAN HL600 Lyse
Medispace Solutions
Quality Control
Brand: EDAN HL600 Lyse
Medispace Solutions
Quality Control
Brand: EDAN HC600
Edan Medical India Pvt Ltd
Quality Control
Brand: EDAN HC600
Edan Medical India Pvt Ltd
Anti-dsDNA IgG (MAGLUMI Anti-dsDNA IgG )
Brand: CLIA
Free T4 (MAGLUMI Free T4 )
Brand: CLIA
ANA Screen (MAGLUMI ANA Screen )
Brand: CLIA
Myoglobin (Maglumi Myoglobin )
Brand: CLIA
LH (MAGLUMI LH )
Brand: CLIA
Vitamin B12 (MAGLUMI Vitamin B12 )
Brand: CLIA
Reaction Module
Brand: CLIA
ENA Screen (MAGLUMI ENA Screen )
Brand: CLIA
Anti-Histones IgG (Maglumi Anti-Histones IgG )
Brand: CLIA
Albumin (Maglumi Albumin )
Brand: CLIA