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CDSCO UID MFG/IVD/2020/000138_515391c8e07366ede4b0c75a2ad7c56f_5f249d0755a1ea588419f634ced68c54

BCR-ABL IS RQ-PCR

BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: Concepta D-DIMER Control
Registration details
UID
MFG/IVD/2020/000138_515391c8e07366ede4b0c75a2ad7c56f_5f249d0755a1ea588419f634ced68c54
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 BCR-ABL test kit is intended for the detection and quantification of the BCR-ABL and ABL transcripts
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Brand: Concepta D-DIMER Control
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Brand: Concepta D-DIMER Control
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About this record

BCR-ABL IS RQ-PCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_515391c8e07366ede4b0c75a2ad7c56f_5f249d0755a1ea588419f634ced68c54. 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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