CDSCO UID MFG/IVD/2023/000081_a466937e0e65605bf6f4081112d269a4_ff49fdbe4699d254fdf0a5ec329747ec
RESIST ACINETO Rapid Test
KILPEST INDIA LIMITED·Device Class Class B·India CDSCO·Brand: TRURAPID® RESIST CTX-M Rapid Test
Registration details
- UID
- MFG/IVD/2023/000081_a466937e0e65605bf6f4081112d269a4_ff49fdbe4699d254fdf0a5ec329747ec
- Device class
- Class B
- Brand name
- TRURAPID® RESIST CTX-M Rapid Test
- License holder
- KILPEST INDIA LIMITED
- Approving authority
- Madhya Pradesh
- Product information
- Acinetobacter baumannii is an important opportunistic and multidrug-resistant Gram-negative bacteria responsible for nosocomial infections in health facilities. If left untreated, this infection can lead to septicemia and death. The carbapenem- hydrolysingoxacillinases (TRURAPID® RESIST CTX-M Rapid Test) are the most commonly reported carbapenem- resistance determinants in Acinetobacter spp., particularly in A. baumannii, with OXA-23 as the most prevalent carbapenem-resistance determinant observed in these isolates. OXA-40 (TRURAPID® RESIST CTX-M Rapid Test) and OXA-58 are also often encountered, and recently Acinetobacter spp. Harbouring OXA’s together with NDM have emerged, particularly because of mobile genetic elements co-harbouring NDM and OXA encoding genes. Mobile genetic elements (TRURAPID® RESIST CTX-M Rapid Test) constitute reservoirs for horizontal transmission of these resistance factors. Detection of these resistance factors, not only in resistant species but also in carrier species, is therefore of paramount importance in the control of antibiotic resistance in the hospital. TRURAPID® RESIST ACINETO Rapid Test test is part of TRURAPID range of antimicrobial resistance diagnostic tests. It is intended to be used by healthcare professionals to aid in the diagnosis of carbapenemases in bacterial culture. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(TRURAPID® RESIST CTX-M Rapid Test) should be considered to confirm the test result obtained by this device
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About this record
RESIST ACINETO Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000081_a466937e0e65605bf6f4081112d269a4_ff49fdbe4699d254fdf0a5ec329747ec. This device is marketed under the brand name TRURAPID® RESIST CTX-M Rapid Test. The license holder is KILPEST INDIA LIMITED, and it is classified as Device Class Class B. The approving authority is Madhya Pradesh.
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