BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA Assay
FDA 510(k) K130268 · Becton, Dickinson & CO
510(k) numberK130268
Submission
- Device name
- BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA Assay
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- February 4, 2013
- Decision date
- August 23, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3860
- Specialty
- Immunology
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
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Questions and answers
When was BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA Assay cleared by the FDA?
BD Probetec Trichomonas Vaginalis (TV) QX Amplified DNA Assay (K130268) received a 510(k) decision of Substantially Equivalent on August 23, 2013, 200 days after the submission was received.
What is the product code of K130268?
The FDA product code is OUY – Trichomonas Vaginalis Nucleic Acid Amplification Test System, a Class II (moderate risk) device regulated under 21 CFR 866.3860.