Vietnam MOH registration 2300066ĐKLH/BYT-TB-CT

Qualitative DNA Test for Streptococcus Group B (GBS)

VN: Thuốc thử xét nghiệm định tính ADN của Streptococcus nhóm B (GBS)

Vietnam·Risk Class TTBYT Loại C·BD MAX GBS·GeneOhm Sciences Canada ULC·Registered Feb 15, 2023

Registration details

Analysis ID: 2300066ĐKLH/BYT-TB-CT
Submission ID: 000.00.04.G18-210727-0013
Product Type: BD MAX GBS
Product Code: 441772

Company information

Manufacturer: GeneOhm Sciences Canada ULC
Manufacturer Country: CANADA

Technical details

Intended Use: BD MAX™ GBS Testing is performed on the BD MAX System and is a qualitative test designed for in vitro diagnostic use to detect the DNA of Group B Streptococcus (GBS) in vaginal-cloacal swab samples collected from pregnant women prior to delivery and cultured in Lim Broth media ≥18 hours. The BD MAX GBS test combines automated DNA extraction to isolate the target nucleic acid from the clinical sample and real-time polymerase chain reaction (PCR) to detect the 124 bp region of the cfb gene on the chromosome of Group B Streptococcus agalactiae. The results from the BD MAX GBS test can be used to support the determination of colonization status in pregnant women. The BD MAX GBS test does not provide information on antibiotic resistance. Culturing and isolation are required to perform the antibiotic resistance testing as recommended for women who are allergic to penicillin. Solid media sub-culturing is required to perform additional tests when indicated.

Dates and status

Registration Date: Feb 15, 2023

About this record

Access comprehensive regulatory information for Qualitative DNA Test for Streptococcus Group B (GBS) 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 2300066ĐKLH/BYT-TB-CT and manufactured by GeneOhm Sciences Canada ULC.

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