Reaction Module - India CDSCO Medical Device Registration
Reaction Module is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000151_d8be4f0d244b32df860f380608ceff37_c185501e906e97da67d79c6f6e6a9ff8. This device is marketed under the brand name CLIA. 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
CLIA
License Holder
Medispace SolutionsDevice Class
Approving Authority
CDSCO
Product Information
Reaction Modules required for the implementation of the MAGLUMI assays on the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer
Testosterone Assay (Testosterone Assay )
Brand: CLIA
Rapid House
MYO Assay (MYO Assay )
Brand: CLIA
Rapid House
Blood Culture Positive Sample Pretreatment Kit
Brand: CLIA
Rapid House
PRL Assay (PRL Assay )
Brand: CLIA
Rapid House
Substrate
Brand: CLIA
Rapid House
FT3 Assay (FT3 Assay )
Brand: CLIA
Rapid House
Mold Sample Pretreatment Kit
Brand: CLIA
Rapid House
Z5 LD Lyse
Brand: CLIA
Rapid House
CK-MB Assay (CK-MB Assay )
Brand: CLIA
Rapid House
T3 Assay (T3 Assay )
Brand: CLIA
Rapid House
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
ENA Screen (MAGLUMI ENA Screen )
Brand: CLIA
Anti-Histones IgG (Maglumi Anti-Histones IgG )
Brand: CLIA
Albumin (Maglumi Albumin )
Brand: CLIA
Unconjugated Estriol (Maglumi Unconjugated Estriol )
Brand: CLIA