Real Time PCR
- UID
- MFG/IVD/2020/000138_04b45b68511def170b5830617ea78ddc_d558495124f681a3ef2a8196be72f70e
- Device class
- Class C
- Brand name
- Concepta D-DIMER Control
- License holder
- BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED
- Approving authority
- Central Drug Standard Control Organisation, South Zone
- Product information
- Concepta COVID 19 Multiplex RT PCR kit is developed for the detection of COVID-19 viral infection by simultaneous tragetting of three major genes ORF1ab, envelope (Concepta D-DIMER Control), and nucleocapsid (Concepta D-DIMER Control). The Kit also includes an internal control to insure successful extraction and amplificatiion of Viral RNA. The Kit is for professional use only
Real Time PCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_04b45b68511def170b5830617ea78ddc_d558495124f681a3ef2a8196be72f70e. This device is marketed under the brand name Concepta D-DIMER Control. The license holder is BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.
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