Vietnam MOH registration 220003785/PCBB-BYT

Hematology Analysis Machine

VN: Máy phân tích huyết học
Vietnam flagVietnam·Risk Class TTBYT Loại B·CELL-DYN Emerald 22 AL Instrument (as per the label: CELL-DYN Emerald 22 AL)·BIT Analytical Instruments GmbH·Registered Dec 30, 2022
Registration details
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)
Company information
Manufacturer Country
65824 Schwalbach
Technical details
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.
Dates and status
Registration Date
Dec 30, 2022
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About this record

Access comprehensive regulatory information for Hematology Analysis Machine in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 220003785/PCBB-BYT and manufactured by BIT Analytical Instruments GmbH.

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