CellaVision DM1200 - India CDSCO Medical Device Registration

CellaVision DM1200 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000420_2f80a791b6344484dda0219e0b1a4477_756e812d6ba96aec22e01b63739e77ff. This device is marketed under the brand name CellaVision DM9600. The license holder is Siemens Healthcare Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

CellaVision DM1200

UID: IMP/IVD/2022/000420_2f80a791b6344484dda0219e0b1a4477_756e812d6ba96aec22e01b63739e77ff

Brand Name

CellaVision DM9600

License Holder

Siemens Healthcare Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

1.1 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 the CellaVision Advanced RBC Application The CellaVision® DM1200 with the CellaVision Advanced RBC Application is an automated celllocating device intended for in-vitro diagnostic use. The CellaVision® DM1200 with the CellaVision Advanced RBC Application automatically locates and presents images of blood cells on peripheral blood smears. The user identifies and verifies the suggested classification of each cell according to type. The CellaVision® DM1200 with the CellaVision Advanced RBC Application is intended for analyzing blood samples that an automated cell counter has flagged as abnormal. CellaVision® DM1200 with the CellaVision Advanced RBC Application is intended for users who are trained in using the analyzer and in recognizing blood cells. 1.1.3 Intended use of the CellaVision Body Fluid Application The CellaVision® DM1200 is an automated system intended for in-vitro diagnostic use. The CellaVision Body Fluid Application is intended for differential count of white blood cells. The analyzer 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. The DM1200 is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.