Company
BD Biosciences, Systems & Reagents
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
15recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2015 | BD Biosciences, Systems & Reagents BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway Terminated |
GKZ | K040725 K041074 +3 |
| Jun 26, 2015 | BD Biosciences, Systems & Reagents BD FACSCalibur;
Catalog Numbers 342973, 342975, 34976
In vitro Diagnostics Use. Terminated |
OYE | K980858 |
| Apr 2, 2015 | BD Biosciences, Systems & Reagents CD123 (9F5) PE
Catalog number 649453
Analyte Specific Reagent Terminated |
MVU | None listed |
| Jan 20, 2015 | BD Biosciences, Systems & Reagents CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046.
Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymph Terminated |
GKL | K904390 |
| Jan 20, 2015 | BD Biosciences, Systems & Reagents Anti-Lambda APC-H7, Catalog Number 656157.
Product Usage:
Intended for in vitro flow cytometric immunophenotyping of hematologic disorders. Terminated |
MVU | None listed |
| Aug 14, 2014 | BD Biosciences, Systems & Reagents BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry. Terminated |
GKZ | K982231 |
| Jul 2, 2014 | BD Biosciences, Systems & Reagents BD FACS Canto and associated Fluidics Cart
Product Usage: Flow cytometer for use in In vitro Diagnostics. Terminated |
OYE | None listed |
| May 1, 2014 | BD Biosciences, Systems & Reagents Anti EpCam PE - Analyte Specific Reagent.
Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting. Terminated |
MVU | None listed |
| Sep 17, 2012 | BD Biosciences, Systems & Reagents BD FACS 7-color Setup beads
BD Biosciences, San Jose, CA 95131.
BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACS Terminated |
GKZ | K040026 |
| Mar 30, 2011 | BD Biosciences, Systems & Reagents CellQuest Pro SW, version 4.0.2. and later;
Becton Dickinson, San Jose, CA 95131
CellQuest Pro software allows you to acquire and analyze data from your flow cytometer on a Macintosh computer. Terminated |
GKZ | K946055 |
| Dec 2, 2010 | BD Biosciences, Systems & Reagents BD Bioscience CD45 APC-H7 Analyte Specific Reagent, manufactured by BD Biosciences, San Jose, CA.
CD45 recognizes members of the T200 family of human leucocyte antigens with molecular mass of 180 to Terminated |
MVU | None listed |
| Nov 3, 2010 | BD Biosciences, Systems & Reagents BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA.
The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow Terminated |
GKZ | None listed |
| Jun 30, 2010 | BD Biosciences, Systems & Reagents BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis Terminated |
GKZ | K050191 |
| Apr 16, 2010 | BD Biosciences, Systems & Reagents BD FACSCount Controls Kit, An Automated Differential Cell Counter, Model/Catalog Number: P/N: 340166,
Product is manufactured and distributed by BD Biosciences, San Jose, CA
The reagents are for in v Terminated |
GKZ | K081213 K933486 |
| Jan 3, 2009 | BD Biosciences, Systems & Reagents BD FACS Sample Prep Assistant (SPA and SPA II) Instrument,
Model Number: 334080,
Product is manufactured and distributed by BD Biosciences, San Jose, CA
The intended use for the BD FACS Sample Prep Terminated |
JQW | None listed |