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BECTON DICKINSON HOLDINGS PTE. LTD.
Class C IVD
Becton, Dickinson and Company
The BD MAX™ GBS Assay as implemented on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in Lim Broth cultures, after incubation for greater than or equal to 18 hours, obtained from vaginal-rectal swab specimens from antepartum pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen and real-time polymerase chain reaction (PCR) to detect a 124bp region of the cfb gene sequence of the Streptococcus agalactiae chromosome. Results from the BD MAX GBS Assay can be used as an aid in determining colonization status in antepartum women. The BD MAX GBS Assay does not provide susceptibility results. Cultured isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women. Subculture to solid media for additional testing when indicated.
Device System Info:[System or Procedure Pack], The BD MAX™ GBS Assay performed on the BD MAX™ System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA in vaginal-rectal specimens from antepartum pregnant women.; Models: BD MAX™ GBS Assay Kit - 441772, BD MAX™ Clinical Instrument - 441916, BD MAX™ Qualification Kit - 442463, Kit Accessories North America MAX - 441940, Kit Starter MAX6 Instrument - 443362, Kit MAX6 Rack Assemblies Locking - 441693, BD MAXTM PCR Cartridges - 437519, Kit Starter W/ Printer MAX6 Instrument - 443363, BD MAX System Software, Version: 4.60A - 443584, BD BBL™ Lim Broth - 296266