CellaVision DC-1 - India CDSCO Medical Device Registration

CellaVision DC-1 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000336_66af3130c54d6727e8ad2bd398e52910_51e7e693fdcff2703f51470fc98c85c1. 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 DC-1

UID: IMP/IVD/2022/000336_66af3130c54d6727e8ad2bd398e52910_51e7e693fdcff2703f51470fc98c85c1

Brand Name

CellaVision DM9600

License Holder

Beckman Coulter India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

CellaVision DC-1 is an automated cell-locating device intended for in-vitro diagnostic use in clinical laboratories. CellaVision DC-1 is intended to be used by operators, trained in the use of the device. 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 (CellaVision DM9600), characterization of red blood cell (CellaVision DM9600) morphology and platelet estimation. The CellaVision DC-1 with the Peripheral Blood Application automatically locates blood cells on peripheral blood (CellaVision DM9600) smears. The application presents images of the blood cells for review. A skilled operator trained in recognition of blood cells, identifies and verifies the suggested classification of each cell according to type.