D-dimer IVD, reagent - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

D-dimer IVD, reagent

UID: IMP/IVD/2022/000064_2416119438078bdc87236bc2996d477a_fb96e8491d18e3bd811c26a4f7f33987

Brand Name

Quidel Triage® TOX Drug Screen, 94600 Control 2

License Holder

Quidel Diagnostics India Pvt Ltd

Device Class

Class C

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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D-dimer IVD, reagent

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

D-dimer IVD, reagent - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

D-dimer IVD, reagent

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