Sickle Cell Rapid Test - India CDSCO Medical Device Registration

Sickle Cell Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_578a3211bbb7984d85c0620e03405a7e_422d3d0bee5ee0a250c6fa4c70ef6d4f. This device is marketed under the brand name Multigene-Multiplex Single tube format. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Sickle Cell Rapid Test

UID: MFG/IVD/2020/000021_578a3211bbb7984d85c0620e03405a7e_422d3d0bee5ee0a250c6fa4c70ef6d4f

Brand Name

Multigene-Multiplex Single tube format

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Sickle Cell rapid test is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingertip or venipuncture whole blood samples. User will be a clinical professional such as a doctor, physician assistant, nurse, clinical or medical assistant, or laboratory technician