GenePath Dx JAK2 v2 Real Time qPCR Test Kit
- UID
- MFG/IVD/2020/000138_3382e663fb11e50baaec8b75987d6133_00e3e9f955849a636ccbc45833e0b024
- 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 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
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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