Reagent for aid to differential diagnosis of hematopoietic neoplasms - India CDSCO Medical Device Registration

Reagent for aid to differential diagnosis of hematopoietic neoplasms is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000114_ae3eddc149d2665e171d4f46e292978f_0070224436b559e90306001990870924. 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

Reagent for aid to differential diagnosis of hematopoietic neoplasms

UID: MFG/IVD/2021/000114_ae3eddc149d2665e171d4f46e292978f_0070224436b559e90306001990870924

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 10C Panels are intended for in vitro diagnostic use for qualitative identification of cell populations by multiparameter immunophenotyping on the Navios, Navios EX and DxFLEX Flow Cytometers. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, the following hematopoietic neoplasms: chronic leukaemia, acute leukaemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (ClearLLab Compensation kit), and/or myeloproliferative neoplasms (ClearLLab Compensation kit). The reagents can be used with peripheral whole blood (collected in K2EDTA, Acid Citrate Dextrose (ClearLLab Compensation kit) or Heparin), bone marrow (ClearLLab Compensation kit) and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings.