Taiwan FDA registration 2299675f5e9ec5df3a9ad8c8f7ab65f9

"Orgentec" Anti-EBV (EBNA-1) IgG (non-sterile)

TW: "歐捷" EB病毒(EBNA-1) IgG抗體試劑 (未滅菌)

Taiwan·Risk Class 1·MD·ORGENTEC DIAGNOSTIKA GMBH·Registered Jul 24, 2015 – Jul 24, 2025Expired

Registration details

Analysis ID: 2299675f5e9ec5df3a9ad8c8f7ab65f9
License Form: Ministry of Health Medical Device Import No. 015512
Customs Code: DHA09401551205

Company information

Manufacturer: ORGENTEC DIAGNOSTIKA GMBH
Manufacturer Country: Germany
Authorized Representative: IN FUNG CO., LTD.

Product details

Intended Use: Limited to the first level identification range of "Epstein-Barr virus serum reagent (C.3235)" of the Measures for the Administration of Medical Devices.
Product Type (Level 1): C Immunology and microbiology devices
Product Type (Level 2): C3235 Epstein-Barr virus serum reagent
Import Information: Imported from abroad

Dates and status

Registration Date: Jul 24, 2015
Expiry Date: Jul 24, 2025

About this record

Access comprehensive regulatory information for "Orgentec" Anti-EBV (EBNA-1) IgG (non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 2299675f5e9ec5df3a9ad8c8f7ab65f9 and manufactured by ORGENTEC DIAGNOSTIKA GMBH. The authorized representative in Taiwan is IN FUNG CO., LTD..

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