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CDSCO UID MFG/IVD/2020/000138_136fb66eec050b0b0a7c8412cdc1c563_1650c68434faf9e73b083ecb254bba15

Concepta CoViDx 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_136fb66eec050b0b0a7c8412cdc1c563_1650c68434faf9e73b083ecb254bba15
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 CoViDx RT-qPCR kit is a single-tube multiplexed real time reverse transcription polymerase chain reaction (Concepta D-DIMER Control) intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (Concepta D-DIMER Control), oropharyngeal (Concepta D-DIMER Control), nasopharyngeal + oropharyngeal (Concepta D-DIMER Control), or nasal swab specimens. Positive results are indicative of active infection. Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. This Concepta CoViDx RT-qPCR kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures
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About this record

Concepta CoViDx RT-qPCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_136fb66eec050b0b0a7c8412cdc1c563_1650c68434faf9e73b083ecb254bba15. 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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