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CDSCO UID IMP/IVD/2023/000472_2416119438078bdc87236bc2996d477a_d82715406b58cf8f68d6870642be96e5

D-dimer IVD, reagent

M/s. Ortho Clinical Diagnostics India Private Limited·Device Class Class C·India CDSCO·Brand: Quidel Triage® Total 5 Control 2
Registration details
UID
IMP/IVD/2023/000472_2416119438078bdc87236bc2996d477a_d82715406b58cf8f68d6870642be96e5
Device class
Class C
Brand name
Quidel Triage® Total 5 Control 2
License holder
M/s. Ortho Clinical Diagnostics India Private Limited
Approving authority
CDSCO
Product information
The Quidel Triage D-Dimer Test is a fluorescence immunoassay to be used withthe Quidel Triage Meters for the quantitative determination of cross-linked fibrin degradationproducts containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. The testis used as an aid in the assessment and evaluation of patients suspected of having disseminatedintravascular coagulation or thromboembolic events including pulmonary embolism
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About this record

D-dimer IVD, reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_2416119438078bdc87236bc2996d477a_d82715406b58cf8f68d6870642be96e5. This device is marketed under the brand name Quidel Triage® Total 5 Control 2. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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