Vietnam MOH registration 2401201ĐKLH/BYT-HTTB

Drug Testing for the Qualitative Complex of Multidrug-Resistant M. tuberculosis

VN: Thuốc thử xét nghiệm định tính phức hợp M. tuberculosis siêu kháng thuốc

Vietnam·Risk Class TTBYT Loại C·GenoType MTBDRsl VER 2.0·Hain Lifescience GmbH·Registered Aug 14, 2024

Registration details

Analysis ID: 2401201ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-220723-0002
Product Type: GenoType MTBDRsl VER 2.0
Product Code: 317A/31796A

Company information

Manufacturer: Hain Lifescience GmbH
Manufacturer Country: GERMANY
Product Owner: Hain Lifescience GmbH
Authorized Representative: CÔNG TY TNHH B.C.E VIỆT NAM

Technical details

Intended Use: GenoType MTBDRsl VER 2.0 is a qualitative in vitro test to determine the complex of Mycobacterium tuberculosis and the fluoroquinolone (FLQ; e.g., ofloxacin and moxifloxacin) and aminoglycosides/peptides ring (AG/CP; injectable antibiotics such as: kanamycin, amikacin, capreomycin, and viomycin) resistance in sputum samples, both positive and negative, and in culture samples. The following species are included in the complex of M. tuberculosis causing tuberculosis (TB): M. tuberculosis, M. africanum, M. bovis subsp. bovis, M. bovis subsp. caprae, M. bovis BCG, M. microti, M. canettii, and M. pinnipedii. The detection of FLQ resistance is activated by the detection of the most important mutations associated with the resistance of the gyrA and gyrB genes (coding for the A and B subunits of DNA gyrase, respectively). To detect AG/CP resistance, the 16S rRNA gene (rrs) is tested, and to detect low-level kanamycin resistance, the promoter region of the eis gene (coding for the acetyltransferase Eis) is tested. The test is intended as a diagnostic support tool and is used in clinical laboratories.

Dates and status

Registration Date: Aug 14, 2024

About this record

Access comprehensive regulatory information for Drug Testing for the Qualitative Complex of Multidrug-Resistant M. tuberculosis in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2401201ĐKLH/BYT-HTTB and manufactured by Hain Lifescience GmbH. The authorized representative in Vietnam is CÔNG TY TNHH B.C.E VIỆT NAM.

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