Taiwan FDA registration d19ab70e316738317a9047b2dc4d8c39

Saibia Third generation capillary heme detection reagent

TW: 賽比亞 第三代毛細管血紅素檢測試劑
Taiwan flagTaiwan·Risk Class 2·SEBIA·Registered Oct 17, 2019 – Oct 17, 2029Active
Registration details
Analysis ID
d19ab70e316738317a9047b2dc4d8c39
Customs Code
DHA05603294401
Company information
Manufacturer
SEBIA
Manufacturer Country
France
Authorized Representative
ARQon Medtech Co., Ltd.
Product details
Intended Use
This product uses capillary electrophoresis to isolate normal heme (A, F and A2) in an alkaline buffer (pH 9.4) and detect the main variants of heme (S, C, E, and D). SUITABLE FOR SEBIA CAPILLARYS 3 INSTRUMENTS.
Product Type (Level 1)
B Hematology, pathology, and genetics
Product Type (Level 2)
B.7440 Heme electrophoresis analysis system
Import Information
import
Dates and status
Registration Date
Oct 17, 2019
Expiry Date
Oct 17, 2029
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About this record

Access comprehensive regulatory information for Saibia Third generation capillary heme detection reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number d19ab70e316738317a9047b2dc4d8c39 and manufactured by SEBIA. The authorized representative in Taiwan is ARQon Medtech Co., Ltd..

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