Becton Dickinson Advanced Diagnostics
Country not established
- Devices
- 10
What Becton Dickinson Advanced Diagnostics makes
Becton Dickinson Advanced Diagnostics manufactures in vitro diagnostic (IVD) assays and testing systems for thyroid function, pregnancy detection, and rapid infectious disease diagnostics. Products include quantitative and qualitative assays for thyroid-stimulating hormone (TSH), human chorionic gonadotropin (HCG), and streptococcal infections, as well as urine and serum-based pregnancy tests. Some solutions are designed for laboratory use, while others are intended for point-of-care testing in physician offices.
The company’s portfolio is regulated under the FDA’s 510(k) pathway, with devices classified as Class I and Class II. Products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. regulatory requirements. The manufacturer operates from the United States.
Catalogue
Iq TT4 Assay Ref K931295
Regimes: 510(k) Registry: 510(k)Precise Tm Hcg Ref K915197
Regimes: 510(k) Registry: 510(k)Precise Strep A Ref K923673
Regimes: 510(k) Registry: 510(k)Iq Tuptake Assay Ref K931294
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Iq Immunochemistry Sistem; Iq Tsh Assay Ref K923060
Regimes: 510(k) Registry: 510(k)Qtest(R) Strep Ref K935667
Regimes: 510(k) Registry: 510(k)Riatrac Plus Ref K914958
Regimes: 510(k) Registry: 510(k)Precise(Tm) Hcg(Urine/Serum) And Prcise(Tm) Preg Ref K926356
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Becton Dickinson Advanced Diagnostics have in the registry?
The registry currently lists 10 devices for Becton Dickinson Advanced Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Becton Dickinson Advanced Diagnostics's devices?
Among its 10 most recently registered devices, Becton Dickinson Advanced Diagnostics has devices listed in FDA 510(k) (10 devices).
What risk classes do Becton Dickinson Advanced Diagnostics's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Becton Dickinson Advanced Diagnostics's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Becton Dickinson Advanced Diagnostics in the registry?
The most recently registered devices listed for Becton Dickinson Advanced Diagnostics include IQ TT4 ASSAY, PRECISE TM HCG, PRECISE STREP A and IQ TUPTAKE ASSAY.