Haematolymphoid malignancies screening Reagent - India CDSCO Medical Device Registration

Haematolymphoid malignancies screening Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000114_8fefd6e709f93f4f5012c4cb763f51e1_47995d0f502e77fbd2acd5ed041dc278. This device is marketed under the brand name ClearLLab Compensation kit. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.

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CDSCO Registered

Class Class C

Haematolymphoid malignancies screening Reagent

UID: MFG/IVD/2021/000114_8fefd6e709f93f4f5012c4cb763f51e1_47995d0f502e77fbd2acd5ed041dc278

Brand Name

ClearLLab Compensation kit

License Holder

Beckman Coulter India Private Limited

Device Class

Class C

Approving Authority

Sub Zonal Bangalore

Product Information

The ClearLLab LS (ClearLLab Compensation kit) reagent is intended for in vitro diagnostic use as a screening panel for identification of various hematolymphoid cell populations by immunophenotyping on Navios and Navios EX Flow cytometers. The reagent is used as an aid in the differential diagnosis of patients with signs and/or symptoms of hematolymphoid malignancies. The reagent can be used with peripheral whole blood (ClearLLab Compensation kit), bone marrow specimens (ClearLLab Compensation kit) and lymph node specimens for immunophenotyping. The results should be interpreted along with additional clinical and laboratory findings. The reagents provide qualitative results for B, T, and NK lineages