Concepta CoViDx RT-qPCR Kit - India CDSCO Medical Device Registration
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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Brand Name
Concepta D-DIMER Control
License Holder
BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITEDDevice Class
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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C-REACTIVE PROTEIN Test Reagent Kit(C-REACTIVE PROTEIN )
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CoviPlus RT-qPCR Kit
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GenePath Dx JAK2 v2 Real Time qPCR Test Kit
Brand: Concepta D-DIMER Control
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Real Time PCR
Brand: Concepta D-DIMER Control
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D-DIMER
Brand: Concepta D-DIMER Control
BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED
Viral Nucleic Acid Extraction Kit
Brand: Concepta Viral Nucleic Acid Extraction Kit
Cytomegalovirus qPCR Test Kit
Brand: Concepta D-DIMER Control
C-REACTIVE PROTEIN Test Reagent Kit(C-REACTIVE PROTEIN )
Brand: Concepta D-DIMER Control
D-DIMER CALIBRATOR
Brand: Concepta D-DIMER Control
CoviPlus RT-qPCR Kit
Brand: Concepta D-DIMER Control
D-DIMER Test Kit
Brand: Concepta D-DIMER Control
BCR-ABL IS RQ-PCR
Brand: Concepta D-DIMER Control
GenePath Dx JAK2 v2 Real Time qPCR Test Kit
Brand: Concepta D-DIMER Control
Real Time PCR
Brand: Concepta D-DIMER Control
D-DIMER
Brand: Concepta D-DIMER Control