BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA Assays
FDA 510(k) K103798 · Becton, Dickinson & CO
510(k) numberK103798
Submission
- Device name
- BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA Assays
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- December 27, 2010
- Decision date
- March 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3305
- Specialty
- Microbiology
A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.
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| K111951 | Isoamp HSV AssayOQO · Traditional | Biohelix Corporation | 09/27/2011SE |
| K111527 | Multicode-Rtx Herpes Simplex Virus 1 & 2 KitOQO · Traditional | Eragen Biosciences, Inc. | 08/03/2011SE |
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Questions and answers
When was BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA Assays cleared by the FDA?
BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified DNA Assays (K103798) received a 510(k) decision of Substantially Equivalent on March 18, 2011, 81 days after the submission was received.
What is the product code of K103798?
The FDA product code is OQO – Herpes Simplex Virus Nucleic Acid Amplification Assay, a Class II (moderate risk) device regulated under 21 CFR 866.3305.