CellaVision DM9600 - India CDSCO Medical Device Registration

CellaVision DM9600 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000420_a7a2f93c07c8e57f874cfe77be799ec0_a9886786c5f86b149b60577f91da1a10. 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 DM9600

UID: IMP/IVD/2022/000420_a7a2f93c07c8e57f874cfe77be799ec0_a9886786c5f86b149b60577f91da1a10

Brand Name

CellaVision DM9600

License Holder

Siemens Healthcare Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

1.1 Intended use of the CellaVision® DM9600 The CellaVision® DM9600 is an automated cell-locating device. The CellaVision® 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. The CellaVision® 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 CellaVision Peripheral Blood Application The CellaVision Peripheral Blood Application is intended for differential count of white blood cells, characterization of red blood cell morphology and platelet estimation. The analyzer 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® DM9600 with the CellaVision Advanced RBC Application is an automated celllocating device intended for in-vitro diagnostic use. The CellaVision® DM9600 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® DM9600 with the CellaVision Advanced RBC Application is intended for analyzing blood samples that an automated cell counter has flagged as abnormal