"Saipei" Mycobacterium tuberculosis detection reagent group - Taiwan Registration 37520e7f0e50161e9b8816f644fb9df4
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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Device Details
Product Details
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.
B Hematology, pathology, and genetics
B.4020 Analysis of specific tests
import
Dates and Status
Jan 16, 2013
Jan 16, 2023