Products/BD MAX CT/GC/TV
Multiplex

BD MAX CT/GC/TV

Becton Dickinson (BD)
510(k) ClearedCE-IVD

Detection of CT, GC, and Trichomonas vaginalis from urogenital specimens

Technical Specifications

PlatformBD MAX
MultiplexYes
Target Count3
Sensitivity≥97%
Specificity≥98%
Turnaround Time3.5 hr
Storage Temperature2–8°C
Shelf Life18 months

Pathogen Targets (2)

Neisseria gonorrhoeae· bacteriaChlamydia trachomatis· bacteria

Sample Types

Urine

Rectal swab

Vaginal swab

Detection Methods

Multiplex PCR

Regulatory Status

FDA510(k) Cleared

K152678

510(k)

2/1/2016

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $20–$38

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.