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South Korea MFDS registration In Vitro Water No. 23-345

HIV· HBV· HCV· HTLV serotype and subtype test reagent

KO: HIV·HBV·HCV·HTLV혈청형·아형검사시약
South Korea flagSouth Korea·Unknown·Siemens Healthineers Co., Ltd.·Approved Oct 26, 2023
Basic information
Item Serial Number
2023006107
License Number
In Vitro Water No. 23-345
체외수허23-345호
Classification Number
K05020.01
Device Class (Risk Classification)
Unknown
Classification Name
HIV· HBV· HCV· HTLV serotype and subtype test reagent
HIV·HBV·HCV·HTLV혈청형·아형검사시약
Official English Name
IVD reagents for serotyping or patient monitoring of HIV, HBV, HCV, HTLV, immunological method
Company information
Entity Name (Company)
Siemens Healthineers Co., Ltd.
지멘스헬시니어스(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 390 호
Important dates & status
Item Approval Date
Oct 26, 2023
Business Permit Date
Apr 04, 2005
Expiration Period
2023-10-26 ~ 2028-10-25
Model information
Model Name
ADVIA Centaur Anti-HBe2 (aHBe2)
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Water No. 23-345. Approved on Oct 26, 2023. Registered by Siemens Healthineers Co., Ltd..

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