Hematology Analysis Machine
- Analysis ID
- 220003785/PCBB-BYT
- Submission ID
- 000.00.04.G18-221230-0040
- Product Type
- CELL-DYN Emerald 22 AL Instrument (as per the label: CELL-DYN Emerald 22 AL)
- Manufacturer
- BIT Analytical Instruments GmbH
- Manufacturer Country
- 65824 Schwalbach
- Intended Use
- The CELL-DYN Emerald 22 AL Hematology Analyzer is an automated, multi-parameter blood analysis instrument used in in-vitro diagnostic testing. It is utilized by medical specialists to assess general health, aiding in the diagnosis and management of conditions related to changes in blood status. The CELL-DYN Emerald 22 AL differentiates and counts the cells in the whole blood of veins and capillaries, which have been anticoagulated with K2EDTA, to provide quantitative results for the following indices: WBC, LYM%, LYM #, MON%, MON #, NEU%, NEU #, EOS%, EOS #, BAS%, BAS #, RBC, HCT, MCV, RDW, HGB, MCH, MCHC, PLT, MPV.
- Registration Date
- Dec 30, 2022
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