Taiwan FDA registration cfabe945646df4bce97dcb4ff5f59628

"Gram tuberculosis" tuberculosis infection diagnosis test tube group

TW: “克肺癆”結核菌感染診斷試管組

Taiwan·Risk Class 3·QIAGEN·Registered Dec 31, 2009 – Dec 31, 2024Expired

Registration details

Analysis ID: cfabe945646df4bce97dcb4ff5f59628
Customs Code: DHA00602077008

Company information

Manufacturer: QIAGEN
Manufacturer Country: United States
Authorized Representative: HOLY STONE HEALTHCARE CO., LTD.

Product details

Intended Use: The Shengtai antigen mimicry protein was used to stimulate the cells in the heparinized whole blood, and then the interferon-r generated by the in vitro reaction of the Shengtai antigen was determined by enzyme-linked immunosorbent analysis to identify whether the test person was infected by Mycobacterium tuberculosis.
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: Dec 31, 2009
Expiry Date: Dec 31, 2024

About this record

Access comprehensive regulatory information for "Gram tuberculosis" tuberculosis infection diagnosis test tube group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number cfabe945646df4bce97dcb4ff5f59628 and manufactured by QIAGEN. The authorized representative in Taiwan is HOLY STONE HEALTHCARE CO., LTD..

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