Chagas Ab Test Device
- UID
- MFG/IVD/2022/000087_a4f1d234c67d09d5512aa11c8981c04f_a8bc6278c6e8027506b0bf2cdc2581e5
- Device class
- Class B
- Brand name
- Urine/Serum
- License holder
- SR Bioera Private Limited.
- Approving authority
- Gujarat
- Product information
- A rapid test for qualitative detection of IgG anti-Trypanosoma cruzi (Urine/Serum) in human serum, plasma or whole blood. It is intended to be used by professionals as a preliminary test result to aid in the diagnosis of infection with Trypanosoma cruzi (Urine/Serum). Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional clinical judgment of health care providers. Alternative test method(Urine/Serum) should be considered to confirm the test result obtained by this test device. For Professional Use
Chagas Ab Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000087_a4f1d234c67d09d5512aa11c8981c04f_a8bc6278c6e8027506b0bf2cdc2581e5. This device is marketed under the brand name Urine/Serum. The license holder is SR Bioera Private Limited., and it is classified as Device Class Class B. The approving authority is Gujarat.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.