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CDSCO UID MFG/IVD/2020/000138_86c413a6e3bbef435330c6297e1c8af1_deb44fa4273916b16b4727f6592b4240

CoviPlus RT-qPCR Kit

BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: Concepta D-DIMER Control
Registration details
UID
MFG/IVD/2020/000138_86c413a6e3bbef435330c6297e1c8af1_deb44fa4273916b16b4727f6592b4240
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
The CoviPlus kit is a combination of a rapid sample preparation reagent and an RT- qPCR test for SARS-CoV2. The proprietary ‘CoviPrep’ reagent enables rapid (Concepta D-DIMER Control) single-step sample preparation and is to be used in conjunction with the RT- qPCR kit. The single-tube multiplexed real time reverse transcription polymerase chain reaction (Concepta D-DIMER Control) is intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (Concepta D-DIMER Control), oropharyngeal (Concepta D-DIMER Control), combined nasopharyngeal + oropharyngeal (Concepta D-DIMER Control), or nasal swab specimens.
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About this record

CoviPlus RT-qPCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_86c413a6e3bbef435330c6297e1c8af1_deb44fa4273916b16b4727f6592b4240. 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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