Taiwan FDA registration b7f0cf9091f89b9f086adce57d4bb564

"Oxford" Tuberculosis Auxiliary Diagnostic Test Kit

TW: 「牛津」肺結核輔助診斷檢測套組

Taiwan·Risk Class 3·OXFORD IMMUNOTEC LTD.·Registered Sep 11, 2009 – Sep 11, 2029Active

Registration details

Analysis ID: b7f0cf9091f89b9f086adce57d4bb564
Customs Code: DHA00602037400

Company information

Manufacturer: OXFORD IMMUNOTEC LTD.
Manufacturer Country: United Kingdom
Authorized Representative: MEDTRUST INTERNATIONAL CO., LTD.

Product details

Intended Use: T-SPOT. TB is an in vitro diagnostic test collected from human whole blood samples of sodium citrate, sodium or lithium heparin anticoagulants, which can be used to assist the diagnosis of Mycobacterium tuberculosis infection by capturing γ interferon near T cells.
Product Type (Level 1): B Hematology, pathology, and genetics
Product Type (Level 2): B.4020 Analysis of specific tests
Import Information: import

Dates and status

Registration Date: Sep 11, 2009
Expiry Date: Sep 11, 2029

About this record

Access comprehensive regulatory information for "Oxford" Tuberculosis Auxiliary Diagnostic Test Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number b7f0cf9091f89b9f086adce57d4bb564 and manufactured by OXFORD IMMUNOTEC LTD.. The authorized representative in Taiwan is MEDTRUST INTERNATIONAL CO., LTD..

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