Abacus 5 Analyzer
- UID
- IMP/IVD/2022/000324_e96ac8cdf38db64019ef2d018f352356_835837172657b174290cee8580068824
- Device class
- Class A
- Brand name
- Diatron
- License holder
- Genworks Health Private Limited
- Approving authority
- CDSCO
- Product information
- The Diatron Abacus 5 System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters in K3EDTA anti-coagulated venous whole blood samples: WBC, LYM%, LYM#, MON%, MON#, NEU%, NEU#, EOS%, EOS#, BAS%, BAS#, RBC, HGB, HCT, MCV, MCH, MCHC, RDWcv, RDWsd, PCT, PDWcv, PDWsd, PLT, MPV, PLCC, and PLCR. The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges
Abacus 5 Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000324_e96ac8cdf38db64019ef2d018f352356_835837172657b174290cee8580068824. This device is marketed under the brand name Diatron. The license holder is Genworks Health Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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