D-Dimer (D-Dimer ) - India CDSCO Medical Device Registration
D-Dimer (D-Dimer ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000104_8c97c31ddb941a41a3b7474197229d86_bf40bcc4af56a5fc3ec0780061753e66. This device is marketed under the brand name CLIA. The license holder is M/s. Peerless Biotech Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
CLIA
License Holder
M/s. Peerless Biotech Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
D- Dimer (CLIA) is a chemiluminescence immunoassay test for the quantitative measurement of circulating D-Dimer in human plasma/whole blood, which is not intended for exclusion and/or aid Diagnosis of venous thromboembolism. The assay can be used for samples over the range of 0.045ฮผg/mL (CLIA) -10ฮผg/mL (CLIA)
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
Blood Collection Needles for single use
Brand: Blood Collection Needles for single use
Sterile Lancets (Safety Lancets )
Brand: use with lancing device
Sterile Lancets (Twist-off lancet )
Brand: use with lancing device
Digital Arm Blood Pressure Monitor
Brand: Digital Arm Blood Pressure Monitor
Sterile Wound Dressings
Brand: HYNAUT
Sterile Wound Plasters
Brand: HYNAUT
Venous Blood Collection Needle(XLPI and XLPII )
Brand: Flashback needle
Mechanical Pipette(Mechanical Pipette )
Brand: TopPette Single Channel Pipettor
Anti-Mรผllerian Hormone (Anti-Mรผllerian Hormone )
Brand: CLIA
Cardiac Troponin I (Cardiac Troponin I )
Brand: CLIA