Taiwan FDA registration 1e289363808c3e1b5944b21a0484fb8e

"Omon immunomembrane strip method anti-TO.R.C.H.IgG reagent system spectrum"

TW: “歐蒙” 免疫膜條法抗TO.R.C.H.IgG試劑系統譜
Taiwan flagTaiwan·Risk Class 2·EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·Registered Dec 12, 2018 – Dec 12, 2028Active
Registration details
Analysis ID
1e289363808c3e1b5944b21a0484fb8e
Customs Code
DHA05603196501
Company information
Manufacturer Country
Germany
Product details
Intended Use
This product is used for the qualitative detection of IgG antibodies to 5 TORCH antigens, including anti-toxoplasmosis, German measles virus, cytomegalovirus (CMV), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), in human serum or plasma, so as to diagnose infections caused by corresponding pathogens.
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C.3305 單純皰疹病毒血清分析;; C.3175 巨細胞病毒血清試劑;; C.3780 弓漿蟲血清試劑
Import Information
import
Dates and status
Registration Date
Dec 12, 2018
Expiry Date
Dec 12, 2028
About this record

Access comprehensive regulatory information for "Omon immunomembrane strip method anti-TO.R.C.H.IgG reagent system spectrum" in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1e289363808c3e1b5944b21a0484fb8e and manufactured by EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG. The authorized representative in Taiwan is EUROIMMUN (SOUTH EAST ASIA) PTE. LTD. TAIWAN BRANCH (SINGAPORE).

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