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Rapid Pregnancy Test Device - India CDSCO Medical Device Registration

Rapid Pregnancy Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000037_910edde66e237f5b8b04920e9ad8f05d_0f24ca3a9428f987a5241bcba60f9da4. This device is marketed under the brand name Urine. The license holder is Oxalis Diagnostics Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered
Class Class B
Rapid Pregnancy Test Device
UID: MFG/IVD/2022/000037_910edde66e237f5b8b04920e9ad8f05d_0f24ca3a9428f987a5241bcba60f9da4

Brand Name

Urine

Device Class

Class B

Approving Authority

Pune Division

Product Information

Rapid Pregnancy Test (Urine) Device is a rapid chromatographic immunoassay for the qualitative detection of human Chorionic Gonadotropin (Urine) in human urine specimen to aid in the early detection of pregnancy. Test is intended for self testing as well as for professional use. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated

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DJ Fang

DJ Fang

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