CDSCO UID IMP/IVD/2022/000336_a7a2f93c07c8e57f874cfe77be799ec0_8cf63dbd2b91d26f3c68bc8832952bf2CellaVision DM9600
- UID
- IMP/IVD/2022/000336_a7a2f93c07c8e57f874cfe77be799ec0_8cf63dbd2b91d26f3c68bc8832952bf2
- Device class
- Class A
- Brand name
- CellaVision DM9600
- License holder
- Beckman Coulter India Private Limited
- Approving authority
- CDSCO
- Product information
- DM9600 is an automated cell-locating device. DM9600 automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. DM9600 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells. 1.1.1 Intended use of the Peripheral Blood Application: The peripheral blood application (CellaVision DM9600) is intended for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. The system automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. 1.1.2 Intended use of Advanced RBC Application: The CellaVision DM9600 with the Advanced RBC Application is an automated cell locating device, intended for in-vitro diagnostic use. The CellaVision DM9600 with the Advanced RBC Application automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The CellaVision DM9600 with the Advanced RBC Application is intended for blood samples that have been flagged as abnormal by an automated cell counter. The CellaVision DM9600 with the Advanced RBC Application is intended to used by skilled operators, trained in the use of the device and in recognition of blood cells. 1.1.3 Intended use of Body Fluid Application: DM9600 is an automated system intended for in-vitro diagnostic use. The body fluid application is intended for differential count of white blood cells. The system automatically locates and presents images of cells on cytocentrifuged body fluid preparations. The operator identifies and verifies the suggested classification of each cell according to type. DM9600 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells
CellaVision DM9600 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000336_a7a2f93c07c8e57f874cfe77be799ec0_8cf63dbd2b91d26f3c68bc8832952bf2. This device is marketed under the brand name CellaVision DM9600. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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