D-Dimer STAT - India CDSCO Medical Device Registration
D-Dimer STAT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000540_745b2e6d6f0f19493cc9306428667b1c_b4a0314262dc6667b93fac61babac3c7. This device is marketed under the brand name LIFOTRONIC. The license holder is PSR Diagnostic 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
LIFOTRONIC
License Holder
PSR Diagnostic Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
Immunoassay for in vitro quantitative determination of D-Dimer in human plasma, which is mainly used for the elimination of venous thrombosis, the auxiliary diagnosis of disseminated intravascular coagulation and the monitoring of thrombolytic therapy
HbAlc Control Material
Brand: LIFOTRONIC
Allied Biotechnology India Pvt. Ltd.
Beta THALASSAEMI A & HbA1c Calibrator
Brand: LIFOTRONIC
Allied Biotechnology India Pvt. Ltd.
HbAlc Calibrator
Brand: LIFOTRONIC
Allied Biotechnology India Pvt. Ltd.
Beta THALASSAEMI A & HbA1c Reagent Kit
Brand: LIFOTRONIC
Allied Biotechnology India Pvt. Ltd.
Beta THALASSAEMI A & HbA1c Control
Brand: LIFOTRONIC
Allied Biotechnology India Pvt. Ltd.
HbA1c Reagent Kit
Brand: LIFOTRONIC
Allied Biotechnology India Pvt. Ltd.
Multi Control Cardiac Marker
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Troponin I
Brand: LIFOTRONIC
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High-Sensitivity Troponin T STAT eCLIA
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N-terminal pro B-type Natriuretic Peptide STAT eCLIA
Brand: LIFOTRONIC
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Automated ECL Immunoassay Analyzer
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Creatine Kinase MB
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Multi Control Cardiac Marker
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Free Thyroxine Kit๏ผElectrochemiluminescence immunoassay๏ผ
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Lipoprotein-Associated Phospholipase A2
Brand: Electrochemiluminescence immunoassay
Troponin I
Brand: LIFOTRONIC
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Brand: Electrochemiluminescence immunoassay
Auffer
Brand: Electrochemiluminescence immunoassay
Thyroglobulin Antibody
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Concentrated Washing Buffer
Brand: Electrochemiluminescence immunoassay

