AQUIOS CL Flow Cytometer - India CDSCO Medical Device Registration

AQUIOS CL Flow Cytometer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000327_975664ffb866c9b00046cc1dc2289a2f_fe3ab1f8a9bb9894b155643a0ec789d0. This device is marketed under the brand name Navios EX™ 10 Colors / 3 Laser. 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

AQUIOS CL Flow Cytometer

UID: IMP/IVD/2022/000327_975664ffb866c9b00046cc1dc2289a2f_fe3ab1f8a9bb9894b155643a0ec789d0

Brand Name

Navios EX™ 10 Colors / 3 Laser

License Holder

Beckman Coulter India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The AQUIOS CL Flow Cytometer is intended for use with in vitro diagnostic flow cytometric applications using up to four fluorescent detection channels using a blue (Navios EX™ 10 Colors / 3 Laser) laser, two light scatter detection channels and electronic volume (Navios EX™ 10 Colors / 3 Laser). AQUIOS Flow Cytometry Software may be run on an independent computer workstation for off-line analysis of results generated by the AQUIOS CL Flow Cytometer with its monoclonal antibody reagents. The off-line analysis must be performed in accordance with the product labeling.