CDSCO UID MFG/IVD/2023/000111_483dab28327300433b0bcd9fc2ee719b_6073db47397548b264e96b2b81e2ed04
Rapid kit Scrub Typhus Ab
S.A-MEDLINE PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: Mediline-SA
Registration details
- UID
- MFG/IVD/2023/000111_483dab28327300433b0bcd9fc2ee719b_6073db47397548b264e96b2b81e2ed04
- Device class
- Class C
- Brand name
- Mediline-SA
- License holder
- S.A-MEDLINE PRIVATE LIMITED
- Approving authority
- CDSCO -North Zone, Ghaziabad
- Product information
- Scrub typhus or Bush typhus is a form of typhus caused by the intracellular parasite Orientia tsutsugamushl, a Gram-negative a-proteobacterium of family Rickettsiaceoe. Scrub typhus is transmitted by some species of trombiculid mites, which are found in areas of heavy scrub vegetation. Symptoms include fever, headache, muscle pain, cough, and gastrointestinal symptoms. More virulent strains of 0. tsutsugamushi can cause hemorrhaging and intravascular coagulation.Tsutsugamushi test was developed using the major surface antigen 56 KDa of representative stains of 0. Tsutsugamushi (Mediline-SA) Tsutsugamushi Ab is a immunochromatographic test for the qualitative detection of antibodies (Mediline-SA) specific to 0. tsutsugomushi in human serum, plasma, and whole blood. T he Tsutsugamushi Ab kit contains a membrane strip, which is pre-coated with recombinant 0. tsutsugamushi capture antigens in the test line (Mediline-SA). The another recombinant antigen-colloid gold conjugate and specimen moves along the membrane chromatographically to the test region (Mediline-SA) and forms o visible line coming from the antigen-antibody-antigen colloid gold particle complex with high degree of sensitivity and specificity. T his test provided only a preliminary diagnostic result and other serological tests like IFA (Mediline-SA), ELISA and PHA must be used in order to confirm 0. Tsutsugamushi infection
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About this record
Rapid kit Scrub Typhus Ab is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000111_483dab28327300433b0bcd9fc2ee719b_6073db47397548b264e96b2b81e2ed04. This device is marketed under the brand name Mediline-SA. The license holder is S.A-MEDLINE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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