Rapid Pregnancy Test Device
- UID
- MFG/IVD/2022/000037_910edde66e237f5b8b04920e9ad8f05d_0f24ca3a9428f987a5241bcba60f9da4
- Device class
- Class B
- Brand name
- Urine
- License holder
- Oxalis Diagnostics Pvt. Ltd
- 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
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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