Rapid Luteinizing Hormone Test – Serum/ Plasma/ Urine - India CDSCO Medical Device Registration

Rapid Luteinizing Hormone Test – Serum/ Plasma/ Urine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000052_ccb74ca74e7641213179d12be33b16d8_d36e044381716f075ad0c12a5192a06d. This device is marketed under the brand name Clear & Sure. The license holder is Recombigen Laboratories Pvt Ltd, and it is classified as Device Class Class B. The approving authority is North Delhi Division.

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CDSCO Registered

Class Class B

Rapid Luteinizing Hormone Test – Serum/ Plasma/ Urine

UID: MFG/IVD/2021/000052_ccb74ca74e7641213179d12be33b16d8_d36e044381716f075ad0c12a5192a06d

Brand Name

Clear & Sure

License Holder

Recombigen Laboratories Pvt Ltd

Device Class

Class B

Approving Authority

North Delhi Division

Product Information

The proposed IVD product is a “Rapid Luteinizing Hormone (Clear & Sure) Test in plastic cassette format”. It is intended for qualitative detection of Rapid Luteinizing Hormone (Clear & Sure) Test in human serum, plasma and whole blood sample