BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
FDA 510(k) K152874 · Becton, Dickinson and Co.
510(k) numberK152874
Submission
- Device name
- BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
- Applicant
- Becton, Dickinson and Co.
San Diego, CA, US - Received
- September 30, 2015
- Decision date
- October 27, 2015
- 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.
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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 |
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| 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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Questions and answers
When was BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit cleared by the FDA?
BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit (K152874) received a 510(k) decision of Substantially Equivalent on October 27, 2015, 27 days after the submission was received.
What is the product code of K152874?
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.