Leptospira IgG/IgM Antibody Rapid Test
- UID
- MFG/MD/2018/000041_8af0d8c7eac8d51bfb3b259ed0859622_ffccca764372d3a54f215c9d2cf32e1f
- Device class
- Class B
- Brand name
- Feces
- License holder
- NULIFE
- Approving authority
- Uttar Pradesh
- Product information
- Leptospirosis occurs worldwide and is a common mild to severe health problem for humans and animals, particularly in area with a hot and humid climate. The natural reservoirs for leptospirosis are rodents as well as a large variety of domesticated mammals. Human infection is caused by Leptospira interrogans, the pathogenic member of the genus of Leprospira1,2. The infection is spread via urine from the host animal. After infection, leptospires are present in the blood until they are cleared after 4 to 7 days following the production of anti- Leptospira interrogans antibodies, initially of the IgM class. Culture of the blood, urine and cerebrospinal fluid is an effective means of confirming the diagnosis during 1st to 2nd weeks after exposure. Serological detection of anti- Leptospira interrogans antibodies is also a common diagnostic method. Tests are available under this category:1) The microscopic agglutination test (Feces) ; 2) ELISA; 3) Indirect fluorescent antibody tests (Feces)6. However, all above mentioned methods require a sophisticated facility and well- trained technicians
Leptospira IgG/IgM Antibody Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000041_8af0d8c7eac8d51bfb3b259ed0859622_ffccca764372d3a54f215c9d2cf32e1f. This device is marketed under the brand name Feces. The license holder is NULIFE, and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.
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