CDSCO UID IMP/IVD/2022/000064_2416119438078bdc87236bc2996d477a_fb96e8491d18e3bd811c26a4f7f33987
D-dimer IVD, reagent
Quidel Diagnostics India Pvt Ltd·Device Class Class C·India CDSCO·Brand: Quidel Triage® TOX Drug Screen, 94600 Control 2
Registration details
- UID
- IMP/IVD/2022/000064_2416119438078bdc87236bc2996d477a_fb96e8491d18e3bd811c26a4f7f33987
- Device class
- Class C
- Brand name
- Quidel Triage® TOX Drug Screen, 94600 Control 2
- License holder
- Quidel Diagnostics India Pvt Ltd
- Approving authority
- CDSCO
- Product information
- The Quidel Triage D-Dimer Test is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular 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/2022/000064_2416119438078bdc87236bc2996d477a_fb96e8491d18e3bd811c26a4f7f33987. This device is marketed under the brand name Quidel Triage® TOX Drug Screen, 94600 Control 2. The license holder is Quidel Diagnostics India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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