Haematolymphoid malignancies screening Reagent
- UID
- MFG/IVD/2021/000114_8fefd6e709f93f4f5012c4cb763f51e1_47995d0f502e77fbd2acd5ed041dc278
- Device class
- Class C
- Brand name
- ClearLLab Compensation kit
- License holder
- Beckman Coulter India Private Limited
- 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
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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