CDSCO UID IMP/IVD/2022/000336_2f80a791b6344484dda0219e0b1a4477_71783a68859d2029e91c6660fb935376

CellaVision DM1200

Beckman Coulter India Private Limited·Device Class Class A·India CDSCO·Brand: CellaVision DM9600

Registration details

UID: IMP/IVD/2022/000336_2f80a791b6344484dda0219e0b1a4477_71783a68859d2029e91c6660fb935376
Device class: Class A
Brand name: CellaVision DM9600
License holder: Beckman Coulter India Private Limited
Approving authority: CDSCO
Product information: DM1200 is an automated cell-locating device. DM1200 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. DM1200 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 DM1200 with the Advanced RBC Application is an automated cell locating device, intended for in-vitro diagnostic use. The CellaVision DM1200 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® DM1200 with the Advanced RBC Application is intended for blood samples that have been flagged as abnormal by an automated cell counter. The CellaVision DM1200 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: DM1200 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. DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells