Taiwan FDA registration 37520e7f0e50161e9b8816f644fb9df4

"Saipei" Mycobacterium tuberculosis detection reagent group

TW: “賽沛”結核分枝桿菌檢測試劑組

Taiwan·Risk Class 3·CEPHEID AB·Registered Jan 16, 2013 – Jan 16, 2023Expired

Registration details

Analysis ID: 37520e7f0e50161e9b8816f644fb9df4
Customs Code: DHA00602431708

Company information

Manufacturer: CEPHEID AB
Manufacturer Country: Sweden
Authorized Representative: PROGRESSIVE GROUP INC.

Product details

Intended Use: Used in conjunction with the Cepheid Xpert System, it is a semi-quantitative nested immediacy PCR in vitro diagnostic reagent. It is used to detect the complex DNA of Mycobacterium tuberculosis in sputum samples or concentrated precipitate samples prepared from induced coughing up sputum, and the acid-fast bacilli smear of the sample is positive or negative. (2) rpoB gene mutations related to rifampicin resistance were detected in samples of patients who may be rifampicin (RIF) resistance. This product is used to detect samples from untreated patients with clinical tuberculosis (TB) present or suspected to have it. Can be used to detect Mycobacterium tuberculosis (MTB) or resistance to rifampicin (RIF) that has not been demonstrated.
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: Jan 16, 2013
Expiry Date: Jan 16, 2023

About this record

Access comprehensive regulatory information for "Saipei" Mycobacterium tuberculosis detection reagent group in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 37520e7f0e50161e9b8816f644fb9df4 and manufactured by CEPHEID AB. The authorized representative in Taiwan is PROGRESSIVE GROUP INC..

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