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/2022/000336_2f80a791b6344484dda0219e0b1a4477_71783a68859d2029e91c6660fb935376. 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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CDSCO Registered

Class Class A

CellaVision DM1200

UID: IMP/IVD/2022/000336_2f80a791b6344484dda0219e0b1a4477_71783a68859d2029e91c6660fb935376

Brand Name

CellaVision DM9600

License Holder

Beckman Coulter India Private Limited

Device Class

Class A

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