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/2023/000145_578a3211bbb7984d85c0620e03405a7e_bbcdd676ac44e9079a4d585adc65b05e. This device is marketed under the brand name SickleCatch™. The license holder is Mylab Discovery Solutions Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Kokan Division.

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CDSCO Registered

Class Class B

Sickle Cell Rapid Test

UID: MFG/IVD/2023/000145_578a3211bbb7984d85c0620e03405a7e_bbcdd676ac44e9079a4d585adc65b05e

Brand Name

SickleCatch™

License Holder

Mylab Discovery Solutions Pvt. Ltd.

Device Class

Class B

Approving Authority

Kokan Division

Product Information

Sickle cell rapid test is lateral flow immuno-chromatographic qualitative assay to aid in rapid diagnosis of sickle cell disorder of hemoglobin A, S and C using whole blood sample (SickleCatch™) to screen individuals of any age (SickleCatch™), including newborns. This In-vitro diagnostic test intended to be used by healthcare professionals