CDSCO UID IMP/IVD/2023/000240_0ab9790d6276a16ef2f5f409d6b60356_7240b3389cc56c97d509d43901a024eaDigital LightCycler Analyzer
- UID
- IMP/IVD/2023/000240_0ab9790d6276a16ef2f5f409d6b60356_7240b3389cc56c97d509d43901a024ea
- Device class
- Class A
- Brand name
- Digital LightCycler Partitioning Engine
- License holder
- Roche Diagnostics India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The Digital LightCycler® System supports a semiautomated workflow to run Polymerase Chain Reaction (Digital LightCycler Partitioning Engine) based Nucleic Acid Testing (Digital LightCycler Partitioning Engine). The system performs digital endpoint PCR analysis of microfluidic partitions, combining the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample partitioning to result interpretation. The Digital LightCycler® System is a semi-automated system for detection and absolute quantification of nucleic acid target copy number, intended for in vitro diagnostic use by professional users in diagnostic and screening laboratories.
Digital LightCycler Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000240_0ab9790d6276a16ef2f5f409d6b60356_7240b3389cc56c97d509d43901a024ea. This device is marketed under the brand name Digital LightCycler Partitioning Engine. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.
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