GenePath Dx JAK2 v2 Real Time qPCR Test Kit - India CDSCO Medical Device Registration
GenePath Dx JAK2 v2 Real Time qPCR Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_3382e663fb11e50baaec8b75987d6133_00e3e9f955849a636ccbc45833e0b024. 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
The GenePath Dx JAK2 v2 Real Time qPCR kit is a qualitative kit for detection of JAK2 V617F mutation [JAK2:c.G1849T (Concepta D-DIMER Control)] in genomic DNA extracted from either EDTA peripheral blood or bone marrow samples. The JAK2 V617F (Concepta D-DIMER Control) mutation present in exon 14 of the JAK2 gene is detected in >95% of patients with Polycythemia Vera (Concepta D-DIMER Control). This kit does not detect any other mutations associated with Myeloproliferative neoplasms, including other mutations in JAK2 exon 14, or mutations in other exons of the JAK2, MPL or CALR genes
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Brand: Concepta D-DIMER Control
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Brand: Concepta D-DIMER Control
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Brand: Concepta D-DIMER Control
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Brand: Concepta D-DIMER Control
BCR-ABL IS RQ-PCR
Brand: Concepta D-DIMER Control
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Brand: Concepta D-DIMER Control
Real Time PCR
Brand: Concepta D-DIMER Control
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Brand: Concepta D-DIMER Control