BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
FDA 510(k) K180438 · Bd
510(k) numberK180438
Submission
- Device name
- BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- Applicant
- Bd
San Diego, CA, US - Received
- February 20, 2018
- Decision date
- March 20, 2018
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Princeton BioMeditech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)FQH · Traditional | 02/20/2026SE |
| K240257 | Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery KitDTK · Special | 02/29/2024SE |
| K232434 | BD Veritor System for Rapid Detection of Flu A+B CLIA Waived KitPSZ · Traditional | 12/05/2023SE |
| K223016 | BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitPSZ · Traditional | 01/27/2023SE |
| K221504 | BD Surgiphor Antimicrobial Irrigation SystemFQH · Traditional | 10/14/2022SE |
| K024240 | BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and KitsJSM · Traditional | 03/26/2003SE |
| K023752 | BD Integra SyringeFMF · Traditional | 02/07/2003SE |
| K021475 | BD Single Lumen Needle, Syringe and Blood Collection SetFMI · Traditional | 07/19/2002SE |
| K020523 | BD Bifurcated Needle, Models 301754, 301755, 301756, 301757SCL · Traditional | 03/20/2002SE |
| K011967 | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, Usp SyringeFOZ · Traditional | 01/23/2002SE |
Questions and answers
When was BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit cleared by the FDA?
BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438) received a 510(k) decision of Substantially Equivalent on March 20, 2018, 28 days after the submission was received.
What is the product code of K180438?
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.