BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
FDA 510(k) K160164 · Becton, Dickinson & CO
510(k) numberK160164
Submission
- Device name
- BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
- Applicant
- Becton, Dickinson & CO
San Diego, CA, US - Received
- January 27, 2016
- Decision date
- February 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSZ – Devices Detecting Influenza A, B, And C Virus Antigens
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3328
- Specialty
- Microbiology
An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.
Other 510(k)s with product code PSZ
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|---|---|---|---|
| K254262 | Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAPSZ · Dual Track | Ortho Clinical Diagnostics Inc. (QuidelOrtho) | 09/04/2026SE |
| K252283 | Nano-Check Influenza A+B TestPSZ · Dual Track | Nano-Ditech Corporation | 01/15/2026SE |
| K250398 | Innovita Flu A/B Antigen Rapid TestPSZ · Traditional | Innovita (Tangshan) Biological Technology Co.… | 07/03/2025SE |
| K241188 | Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 04/18/2025SE |
| K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived KitPSZ · Traditional | Bd | 12/05/2023SE |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ · Traditional | Bd | 01/27/2023SE |
| K192719 | Osom Ultra Plus Flu A&B Test KitPSZ · Dual Track | SEKISUI Diagnostics, LLC | 04/03/2020SE |
| K191514 | CareStart Flu A&B PlusPSZ · Dual Track | Access Bio, Inc. | 02/18/2020SE |
| K182001 | Acucy Influenza A&B Test with the Acucy SystemPSZ · Dual Track | SEKISUI Diagnostics, LLC | 12/17/2018SE |
| K182157 | BioSign Flu A+BPSZ · Special | Princeton BioMeditech Corp. | 09/18/2018SE |
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| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)LON · Traditional | 03/21/2017SE |
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| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | 08/08/2016SE |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ · Special | 02/24/2016SE |
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Questions and answers
When was BD Veritor System for Rapid Detection of Flu A + B Labratory Kit cleared by the FDA?
BD Veritor System for Rapid Detection of Flu A + B Labratory Kit (K160164) received a 510(k) decision of Substantially Equivalent on February 25, 2016, 29 days after the submission was received.
What is the product code of K160164?
The FDA product code is PSZ – Devices Detecting Influenza A, B, And C Virus Antigens, a Class II (moderate risk) device regulated under 21 CFR 866.3328.