D-Dimer Fast Test Kit - India CDSCO Medical Device Registration

D-Dimer Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000153_22baa3c5d442386e282c23f1edb784a9_4d36401e5e422aa56dbc8fc65e09669d. This device is marketed under the brand name Immunofluorescence Assay. The license holder is Cipla Limited, 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 Fast Test Kit

UID: IMP/IVD/2022/000153_22baa3c5d442386e282c23f1edb784a9_4d36401e5e422aa56dbc8fc65e09669d

Brand Name

Immunofluorescence Assay

License Holder

Cipla Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

D-Dimer Fast Test Kit (Immunofluorescence Assay) is intended for in vitro quantitative determination of D-Dimer in plasma or whole blood. The test is used for professional person as an aid in the assessment and evaluation of patients suspected of deep-vein thrombosis or pulmonary embolism.