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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