Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1017835

FEI Number

1017835

Entity Name

BECKMAN COULTER, INC.

City/State/Country

HIALEAH, FL, US

Establishment Address

740 WEST 83RD ST., HIALEAH, FL 33014, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BECKMAN COULTER, INC. (Owner Number: 2050012)

Owner / Operator Contact Address

250 S. Kraemer Blvd, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hemoccult SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Developer (PN 64115) Hemoccult SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Single Slides (PN 64151) Gastroccult Test for Gastric Occult Blood and pH Developer/15 mL (PN 66115) Hemoccult Routine Screening Test for Fecal Occult Blood Single Slides (PN 60151) Hemoccult II Serial Test For Routine Screening for Fecal Occult Blood Dispensapak Patient Kits (PN 61100) Gastroccult Test for Gastric Occult Blood and pH 40 Test Slides (PN 66040) Hemoccult II Serial Test For Routine Screening for Fecal Occult Blood Slides (PN 61200) Hemoccult Routine Screening Test for Fecal Occult Blood Tape with Developer (63202) Hemoccult II Serial Test For Routine Screening for Fecal Occult Blood Dispensapak Plus (PN 61130) Gastroccult 40 Applicator Straws (PN 66140) Hemoccult Mailing Pouches (PN 62200) Hemoccult SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Single Slides (PN 64152) Hemoccult Routine Screening Test for Fecal Occult Blood Developer (PN 62115) Hemoccult Routine Screening Test for Fecal Occult Blood Single Slides (60152) Hemoccult II SENSA Sensitive Test for Enhanced Detection of Fecal Occult Blood Dispensapak Plus (PN 64130) CD10-APC-Alexa Fluor 700, 0.5 ML ASR CD19-PE, 2ML, ASR CD4-Krome Orange, 0.5 ML ASR CD36-APC-Alexa Fluor 700, 0,5 ml, ASR CD10-FITC, 2ML, ASR CD66c (KOR-SA3544)-PE, 1ML, ASR CD28-APC, 0.5 ML ASR CD3, 0.2MG, ASR CD3-ECD, 1ML, ASR CD65-Pacific Blue, 0.5 ML ASR CD8-Alexa Fluor 700, 0.5 ml, ASR CD45-APC-Alexa Fluor 750, 1ML ASR CD159a-PC7, 0.5 ML ASR CD7-APC-Alexa Fluor 700, 0.5 ML ASR CD123-PE, 2ML ASR Anti-TCR Vbeta11-PE, 1ML, ASR CD18-FITC, 2ML, ASR CD5-PC5.5, 0.5 ML ASR CD14-APC, 1ML, ASR CD7-APC-Alexa Fluor 750, 0.5 ML ASR CD3-PE, 2ML, ASR CD8-SNv786, 0.5 ML, ASR CD22-APC, 0.5 ML ASR CD85k (ILT3)-PC7, 1ML ASR CD314 (NKG2D)-APC, 0.5 ML ASR CD134 (OX 40)-APC, 0.5 ML ASR CD244-PC5.5, 0.5 ML ASR CD59-PE, 1ml, ASR CD20-SNv650, 0.5 ML, ASR Anti-TCR Vbeta22-FITC, 1ML, ASR CD20-PC5, 1ML, ASR CD5-FITC, 2ML, ASR CD36-FITC, 2ML, ASR CD2-PC7, 1ML ASR Anti-Myeloperoxidase-PE, 2ML, ASR CD8-PC5.5, 0.5 ML ASR CD6-FITC, 1ML, ASR Anti-Myeloperoxydase-FITC, 2ML, ASR CD161-APC-Alexa Fluor 750, 0.5 ML ASR CD41-FITC, 2ML, ASR CD62L-APC, 0.5 ML ASR Anti-HLA-DR-Krome Orange, 0.5 ML ASR CD200-SNv428, 0.5 ML, ASR CD34-PE, 2ML, ASR CD9-FITC, 2ML, ASR CD25-PC5.5, 0.5 ML ASR CD90 (Thy-1)-APC-Alexa Fluor 750, 0.5 ML ASR CD137-ECD, 0.5 ml, ASR CD58-APC , 1ML, ASR CD196-PC7, 0.5 ML, ASR CD56-PC5.5, 0.5 ML ASR CD158a,h-APC, 0.5 ML ASR CD86 (B7-2)-PC5.5, 0.5 ML ASR CD21-PE, 2ML ASR CD22-Pacific Blue, 0.5 ML ASR CD309-PC7, 1ML ASR CD200-SNv786, 0.5 ML ASR Anti-TCRV alpha24-PC7, 0.5 ML ASR CD56-SNv428, 0.5 ML ASR CD105-PC7, 0.5 ML, ASR CD161-PE, 1ML, ASR CD24-APC, 0.5 ML ASR Anti-IFN-GAMMA-FITC, 2ML, ASR CD138-SNv428, 0.5 ML ASR Anti-IL4-PC7, 0.5 ML ASR CD144-PE, 2ML ASR IgM(Mouse)-FITC, 2ML, ASR Anti-TNFalpha PE, 2ML, ASR CD1a-APC , 1ML, ASR CD15-PE, 2ML, ASR CD20-Pacific Blue, 0.5 ML ASR CD14-APC-Alexa Fluor 750, 0.5 ML ASR CD117-SNv786, 0.5mL ASR CD2-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR PAN alpha/beta-PC5, 0.5 ML ASR CD2-APC, 1ML ASR CD69-PC7, 1ML, ASR Anti-Human IgE (D 2), 0.2 mg ASR CD64-ECD, 0.5 ML ASR CD11b-PE, 2ML, ASR CD40-APC, 0.5 ML ASR CD19-Krome Orange, 0.5 ML ASR CD278 (ICOS)-APC, 0.5 ML ASR Purified CD14, 0.2MG, ASR CD18-PE, 2ML, ASR CD16-APC-Alexa Fluor 750, 0.5 ML ASR CD79a-PE, 2ML, ASR Anti-TCR Vbeta2-FITC, 1ML, ASR CD8-Krome Orange, 0.5 ML ASR CD25-PE, 2ML, ASR Anti-TCR Pan g/d-PC7, 0.5 ML ASR Anti-TCR Vbeta13.2-PE, 1ML, ASR CD81-PE, 2ML, ASR CD159a PE, 1ML, ASR CD25-Pacific Blue, 0.5 ML ASR CD45RA-Alexa Fluor 700, 0.5 ML ASR Anti-IFN gamma-Pacific Blue, 0.5 Ml, ASR CD19-ECD, 1ML, ASR CD16-PC5, 1ML, ASR CD45-APC, 1ML, ASR CD13-PC5, 1ML, ASR CD80-PC7, 0.5 ML ASR CD180-PE, 1ml, ASR CD45RA-FITC, 2ML, ASR CD10-ECD, 1ML, ASR CD43-FITC, 2ML, ASR CD56-PE, 2ML, ASR CD33-PC5, 1ML, ASR CD4-BIOTIN, 0.2 MG, ASR CD11a-PE, 2ML, ASR Anti-Perforin-Pacific Blue, 0.5 ML, ASR CD19-APC-Alexa Fluor 700, 0.5 ML ASR CD57-Pacific Blue, 0.5 ML ASR CD337 (NKp30)-PC5, 0.5 ML ASR CD43-PE, 2ML ASR Anti-Cyclin A2-PE, 1ML, ASR Anti-TCR Vbeta22- PE, 1ML, ASR CD64-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Vbeta11-FITC, 1ML, ASR CD3-Pacific Blue, 0.5 ML ASR CD40-PE, 2ML, ASR CD64-PC7, 0.5 ML ASR CD9-Pacific Blue, 0.5 ML ASR CD45-ECD, 1ML, ASR CD5-APC, 0,5ml, ASR CD11a-FITC, 2ML, ASR CD123-APC-Alexa Fluor 700, 0.5 ML ASR CD45-PC5, 1ML, ASR CD66c (KOR-SA3544)-FITC, 1ML, ASR CD39-PE, 1Ml, ASR CD34-APC-Alexa Fluor 750, 0.5 ML ASR CD20-APC, 1ML ASR CD138-PC5.5,0.5 ML ASR CD34-PC5, 1ML, ASR CD62L-PC5, 1ML, ASR CD103-SNv786, 0.5 ML ASR CD23-PE, 2 ML ASR CD31-FITC, 2ML, ASR CD4-APC-Alexa Fluor 700, 0.5 ML ASR CD158a,h-PE, 1ML ASR Anti-TCR Vbeta13.6-FITC, 1ML, ASR CD1a-PC5, 1ML, ASR Anti-TCR Vgamma9-FITC, 1ML, ASR CD20-APC-Alexa Fluor 700, 0.5 ML ASR CD28-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Vbeta14-FITC, 1ML, ASR CD11c-APC-Alexa Fluor 700, 0.5 ML, ASR CD45RA-APC, 0.5 ML ASR CD9-APC-Alexa Fluor 750, 0.5 ML ASR CD158b1/b2,j-PE, 1ML, ASR CD49d-FITC, 2ML, ASR CD107a-APC, 0.5 ML ASR CD24-ECD, 0.5 ML ASR CD14-FITC, 2ML, ASR CD11c-PE, 2ML, ASR CD4-APC-Alexa Fluor 750, 0.5 ML ASR CD61-FITC, 2ML, ASR CD45RA-APC-Alexa Fluor 750, 0.5 ML ASR CD274-APC, 0.5 ML, ASR Anti-Lambda-PE, 2ML ASR Anti-TCR PAN gamma/delta-PC5, 0.5 ML, ASR Anti-TCR Vbeta 23-PE, 1ML, ASR CD4-FITC, 2ML, ASR Anti-TCR Vbeta16-FITC, 1ML, ASR CD19-PC5.5, 0.5 ML ASR CD38-PE, 2ML, ASR CD38-SNv428, 0.5 Ml ASR CD4-APC, 1ML, ASR CD158e1/e2-PE, 1ML, ASR Anti-TCRgamma/delta-PC5.5, 0.5 ML ASR CD42b-APC, 0.5 ML ASR CD79b-APC, 0.5 ML ASR Anti-TCR vd2-Pacific Blue, 0,5 ml, ASR CD158i (KIR2DS4)-APC, 0.5 ML ASR Anti-TCR Vbeta17-PE, 1ML, ASR CD90 (Thy-1)-Pacific Blue, 0.5 ML ASR Anti-Kappa-FITC (Goat Polyclonal), 2ml ASR IgG2a-PE (Mouse), 2ML ASR CD326 (EpCam)-APC, 0.5 ML ASR CD19-PC5, 1ML, ASR CD54-FITC, 2ML, ASR CD8-ECD, 0.5 ML ASR CD45RA-PC7, 0.5 ML ASR CD20-Alexa Fluor 700, 0.5 ML, ASR CD8-PC5, 1ML, ASR CD184 (CXCR4)-PE, 2ML ASR CD49e-FITC, 2ML, ASR CD5-Pacific Blue, 0.5 ML ASR CD146-PE, 2ML ASR CD235a-PC7, 1ML ASR CD38-PC5, 1ML, ASR CD56-APC-Alexa Fluor 750, 0,5 ml, ASR CD103-APC, 0.5 ML ASR CD127-APC-Alexa Fluor 700, 0.5 ML ASR CD13-SNv428, 0.5 ML ASR CD61-PC7, 1ML, ASR CD66b-APC, 0.5 ML ASR CD5-SNv428, 0.5 ML ASR CD117-APC-Alexa Fluor 750, 0.5 ML ASR CD7-FITC, 2ML, ASR CD20-ECD, 1ML, ASR Anti-TCR PAN gamma/delta-PE, 1ML, ASR CD22-ECD, 0.5 ML ASR CD19, 0.2MG, ASR CD158I-PE, 1ML, ASR CD27-APC, 0.5 ML ASR Anti-APO2.7-PE, 2ML, ASR IgG1(mouse)-APC-Alexa Fluor 700, 1ML ASR Anti-TCR Vbeta3-FITC, 1ML, ASR CD7-SNv786, 0.5 ML, ASR Anti-TCR Vbeta13.1-PE, 1ML, ASR CD38-PC7, 0.5 ML ASR Anti-TCR Vbeta8-PE, 1ML, ASR CD300a (IRp60)-PE, 1ML ASR CD42b-PE, 2ML, ASR CD235a-PE, 2ML, ASR Anti-TCR Vbeta1-FITC, 1ML, ASR Anti-Clec9a-APC, 0.5 ML, ASR CD158a,h-PC7, 0.5 ML ASR CD294-FITC, 1ML, ASR CD33-FITC, 2ML, ASR CD159a (NKG2a)-APC, 0.5 ML ASR CD62L-APC-Alexa Fluor 750, 0.5 ML ASR CD14-Krome Orange, 0.5 ML ASR Anti-TCR Vbeta13.6-PE, 1ML, ASR CD8-Pacific Blue, 0.5 ML ASR Anti-TCR Vbeta 5.3-PE, 1ML, ASR CD314 (NKG2D)-PE, 1ML ASR Anti-HLA-DR-PC7, 0.5 ML ASR CD86 (B7-2)-PE, 2ML, ASR CD23-ECD, 1ML, ASR CD15-PC5, 1ML, ASR Anti-TCR Vbeta12-FITC, 1ML, ASR CD5-APC, 1ML ASR CD14-APC-Alexa Fluor 700, 0.5 ML ASR CD58-PE, 2ML, ASR CD27-PE, 2ML, ASR CD235a-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Vbeta5.2-PE, 1ML, ASR CD24-PC5, 1ML, ASR CD13-ECD, 1ML ASR CD8-PE, 2ML, ASR CD200-PC7, 0.5 ML, ASR CD52-PC7, 0.5 ML, ASR CD305-PE, 1ML, ASR CD5-PC5, 1ML, ASR CD8-APC-Alexa Fluor 700, 0.5 ML ASR CD7-APC, 0.5 ML, ASR Anti-Kappa-APC (Goat Polyclonal), 0.5 ML ASR CD34-SNv428, 0.5 ML, ASR CD7-ECD, 1ML ASR IgG2a(Mouse)-ECD (Mouse), 1ML ASR CD49d-APC, 0.5 ML ASR CD56-PC5, 1ML, ASR CD49d-APC-Alexa Fluor 750, 0.5 ML ASR CD56-APC-Alexa Fluor 700, 0.5 ML ASR CD20-FITC, 2ML, ASR CD24-PE, 2ML, ASR CD2-FITC, 2ML, ASR CD45RO-ECD, 1ML, ASR Anti-TCR Vbeta 9-PE, 1ML, ASR CD19-SNv428, 0.5 Ml ASR CD3-APC-Alexa Fluor 700, 0.5 ML ASR CD157-PE, 1ml, ASR CD83-PE, 2ML, ASR Anti-NKp80-PE, 1ML ASR CD5-PC7, 1ML ASR CD10-PC5.5, 0.5 ML ASR CD279 (PD-1)-PC5.5, 0.5 ML ASR CD13-FITC, 2ML, ASR Anti-TCR Vbeta7-FITC, 1ML, ASR CD309-PE, 2ML ASR Anti-FoxP3-Alexa Fluor 647, 0.5 ML ASR CD62L-Pacific Blue, 0.5 ML ASR CD159a, 0.2MG, ASR CD34-PC7, 1ML ASR Anti-HLA-DR-PE, 2ML, ASR CD54-PE, 2ML, ASR CD2-Pacific Blue, 0.5 ML ASR Anti-TIA-1-PE, 2ML, ASR CD45-PC7, 1ML, ASR CD8-APC, 1ML, ASR CD3-FITC, 2ML, ASR Anti-Kappa-FITC, 2ML ASR CD44-FITC, 2ML, ASR CD62L-PE, 2ML, ASR IgG1(mouse)-APC-Alexa Fluor 750, 1ML ASR CD45R0-PC7, 0.5 ML ASR CD62L-PC7, 0.5 ML ASR CD3-PC5, 1ML, ASR Anti-TdT (POOL)-FITC, 1ML, ASR CD3-SNv428, 0.5 ML ASR CD90-PC5, 1ML, ASR CD28-PE, 2ML, ASR CD200-PE, 1ml, ASR CD56-SNv650, 0.5 ML, ASR Anti-HLA-DR-SNv428, 0.5 ML ASR Anti-TCR Vbeta18-PE, 1ML, ASR CD127-APC, 0.5 ML, ASR CD11b-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Valpha24-PE, 1ML, ASR CD4-Pacific Blue, 0.5 ML ASR CD207-PE, 2ML, ASR CD23-PC7, 0.5 ML ASR CD117-PC5.5, 0.5 ML ASR CD45RA-ECD, 1ML, ASR CD45-Pacific Blue, 1ML ASR CD197 (CCR7)-PC7, 0,5 ml, ASR CD34-ECD, 1ML, ASR CD8beta-FITC, 50t, ASR CD25-SNv650, 0.5 ML, ASR Anti-TCR Vbeta14-PE, 1ML, ASR CD58-FITC, 2ML, ASR CD33-SNv650, 0.5 ML, ASR CD85j (ILT2)-APC, 0.5 ML ASR CD80-APC-Alexa Fluor 750, 0.5 ML ASR CD8-FITC, 2ML, ASR CD105-PE, 1 ml, ASR CD23-FITC, 2ML, ASR CD4-PC5, 1ML, ASR Anti-IL-4-PE, 2ml ASR CD45RO-FITC, 2ML, ASR CD23-SNv786, 0.5 ML, ASR CD73-PE, 1ml, ASR Anti-FMC7-FITC, 1ML, ASR Anti-TCR Vbeta4-PE, 1ML, ASR CD38-APC-Alexa Fluor 700, 0.5 ML ASR Anti-Myeloperoxydase-PC5.5, 0.5 ML ASR CD79a-APC, 1ML ASR Anti-ZAP-70-PE, 1 ML, ASR Anti-TCR Vbeta1-PE, 1ML, ASR CD19-Alexa Fluor 700, 0.5 ml, ASR CD22-SNv428, 0.5 ML, ASR CD28-FITC, 2ML, ASR CD28-APC-Alexa Fluor 700, 0.5 ML ASR CD200-APC-Alexa Fluor 750, 0.5 ML, ASR Anti-HLA-DR-APC-Alexa Fluor 750, 0.5 ML, ASR CD45RA-Pacific Blue, 0.5 ML ASR CD20-APC-Alexa Fluor 750, 0.5 ML ASR CD38-ECD, 0.5 ML ASR CD1a-PE, 2ML, ASR Anti-TCR Vbeta7.2-FITC, 1ML, ASR Anti-TCR PAN a/b-APC, 0.5 ML ASR Anti-TCR Vbeta5.1-PE, 1ML, ASR CD22-APC-Alexa Fluor 700, 0.5 ML ASR Anti-TCR Vbeta13.1-FITC, 1ML, ASR CD33-APC-Alexa Fluor 750, 0.5 ML ASR CD45RO-PE, 2ML, ASR CD7-Pacific Blue, 0.5 ML ASR CD79a-PC5.5, 0.5 ML, ASR CD117-ECD, 0.5 ML ASR CD22-PC5, 1ML, ASR Anti-FoxP3-PE, 1 Ml, ASR CD160-PE, 2ML, ASR CD25-PC5, 1ML, ASR CD16-Krome Orange, 0.5 ML ASR CD42b-FITC, 2ML, ASR CD27-Pacific Blue, 0.5 ML ASR CD34-APC-Alexa Fluor 700, 0.5 ML ASR CD10-SNv428, 0.5 ML ASR CD14-Pacific Blue, 0.5 ML ASR Anti-IFN-GAMMA-PE, 2ML, ASR CD94-Pacific Blue, 0.5 ML ASR Anti-Lambda-PC7 (Goat Polyclonal), 0.5Ml ASR CD138-APC, 0.5 ML ASR CD7-PC5, 1ML, ASR CD15-FITC, 2ML, ASR Anti-TCR Vbeta17-FITC, 1ML, ASR CD79b-PE, 2ML, ASR CD107a-Pacific Blue, 0.5 ML ASR IgG2a(Mouse)-PC5 (Mouse), 1ML ASR CD14-SNv650, 0.5 ML, ASR CD86 (B7-2)-PC7, 0.5 ML ASR CD45RO-PC5.5, 0.5 ML ASR CD30-APC-Alexa Fluor 700, 0.5 ML, ASR CD56-ECD 1ML, ASR CD29-FITC, 2ML, ASR CD27-PC7, 1ML ASR CD10-APC-Alexa Fluor 750, 0.5 ML ASR CD34-APC, 1ML, ASR CD62P-PE, 2ML, ASR Anti-HLA-DR-PC5.5, 0.5 ML ASR CD123-APC, 0.5 ML ASR CD279 (PD-1)-PE, 1ML, ASR CD38-APC, 1ML ASR CD141-FITC, 50t, ASR CD11b-FITC, 2ML, ASR CD71-APC-Alexa Fluor 750, 0.5 ML ASR CD41-APC, 0.5 ML ASR CD335 (NKp46)-PC5, 0.5 ML ASR Anti-FoxP3-PC7, 0.5 Ml, ASR Anti-TCR PAN gamma/delta-SNv428, 0.5 ML ASR CD158a,h-PC5.5, 0.5 ML ASR Anti-TCR VBeta20-PE, 1ML, ASR CD14-PC7, 1ML ASR CD5-PE, 2ML, ASR CD10-PC7, 1ML ASR CD31-Pacific Blue, 0.5 ML ASR CD14-ECD, 1ML, ASR CD158b1/b2,j-PC5.5, 0.5 ML ASR Anti-TCR vd1-PC7, 0,5 ml, ASR CD3-Purified 2ML ASR CD81-Pacific Blue, 0.5 ML ASR CD146-PC5, 1ML ASR CD117-SNv428, 0.5 ML, ASR IgG1(Mouse)-PE, 2ML, ASR CD25-PC7, 1ML ASR Anti-TCR zeta-PE, 2ML, ASR CD57-FITC, 2ML, ASR CD19-PC7, 1ML, ASR CD19-Pacific Blue, 0.5 ML ASR CD45-PC5.5, 1ML ASR CD4, 0.2 MG, ASR CD203c (E-NPP3)-PC7, 1ML ASR CD19-APC, 1ML, ASR Anti-IL-4-PE, 2ML, ASR CD69-APC, 1ML, ASR CD3-PC5.5, 0.5 ML ASR CD36-APC, 0.5 ML ASR IgG1(Mouse)-FITC, 2ML, ASR Anti-HLA-DR-PC5, 1ML, ASR CD16-APC, 0.5 ML ASR CD69-PE, 2ML, ASR CD45-PE, 2ML, ASR CD38-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Vbeta5.2-FITC, 1ML, ASR CD7-PC7, 1ML ASR CD203c-PE, 2ML, ASR CD13-PC5.5, 0.5 ML ASR CD44-APC-Alexa Fluor 750, 0.5 ML ASR CD30-PE, 2ML, ASR CD25-APC-Alexa Fluor 750, 0.5 ML ASR CD42a-FITC, 2ML, ASR CD27-PC5.5, 0.5 ML ASR Anti-HLA-DR-APC, 1ML, ASR Anti-HLA-DR-ECD , 1ML, ASR CD2-APC-Alexa Fluor 700, 0.5 ML ASR CD3-Krome Orange, 0.5 ML ASR CD71-PE, 2ML, ASR CD336 (NKp44)-PC5, 0.5 ML ASR CD127-PE, 2ML, ASR CD123-ECD, 0.5 ML ASR Anti-CYTOKERATIN-FITC, 2ML, ASR CD33-APC, 1ML, ASR CD65-FITC, 2ML, ASR CD20-PC7, 1ML, ASR CD138-Krome Orange, 0,5 ml, ASR CD127-PC5, 1ML ASR CD20-PC5.5, 0.5 ML ASR CD206 (MMR)-PC7, 0.5 ML ASR CD22-SNv605, 0.5 ML, ASR CD335 (NKp46)-PC7, 0.5 ML ASR CD138-PC5, 1ML ASR Anti-Cyclin A2-FITC, 2ML ASR Anti-TCR Vbeta12-PE, 1ML, ASR Anti-HLA-DR-FITC, 2ML, ASR IgG2a(Mouse)-APC, 1ML ASR CD335 (NKp46)-PE, 1ML, ASR CD158e1/e2-APC, 0.5 ML ASR CD127-FITC, 1ML, ASR Anti-HLA-DR-Pacific Blue, 0.5 ML ASR CD38(VHH)-Alexa Fluor 488, 0.5 ML, ASR CD24-PC5.5, 0.5 ML ASR CD183-Alexa Fluor 488, 0.5Ml, ASR CD16-PE, 2ML, ASR CD90-FITC, 2ML, ASR CD127-PC7, 1ML ASR CD71-APC-Alexa Fluor 700, 0.5 ML ASR CD20-PE, 2ML, ASR CD14-PC5, 1ML, ASR CD45-FITC, 2ML, ASR CD19-APC-Alexa Fluor 750, 0.5 ML ASR CD26-PE, 2ML, ASR Anti-FMC7-Pacific Blue, 0.5 ML ASR CD20-SNv428, 0.5 ML, ASR Purified CD16, 0.2MG, ASR CD45RA-PE, 2ML, ASR CD243-PE, 2ML, ASR IgG1(Mouse)-PC5, 1ML, ASR CD33-PE, 2ML, ASR CD8-APC-Alexa Fluor 750, 0.5 ML ASR CD16-APC-Alexa Fluor 700, 0.5 ML ASR CD23-APC, 1ML ASR CD206 (MMR)-Pacific Blue, 0.5 ML ASR CD38-FITC, 2ML, ASR CD117-APC , 1ML, ASR CD11b-APC, 0.5 ML ASR CD336 (NKp44)-PE, 1ML, ASR CD138-PE, 2ML ASR CD43-APC-Alexa Fluor 750, 0.5 ML ASR CD63-FITC, 2ML, ASR CD11c-APC, 0.5 ML ASR Anti-Thrombin Receptor-PE, 2ML, ASR CD39-PC5.5, 0,5ml, ASR CD32-PE, 2ML, ASR CD123-PC7, 0.5 ML ASR CD337 (NKp30)-PE, 1ML, ASR CD279 (PD-1)-APC, 0.5 ML ASR CD61-PE, 2ML, ASR Anti-TCR C-Beta-1 (TRBC1)-SNv428, 0.5 ML, ASR CD123-PE, 1ML, ASR CD99-APC, 0.5 ML, ASR CD279 (PD-1)-PC7, 0.5 ML ASR CD25-APC, 0.5 ML ASR CD79a-PC5, 1ML, ASR CD161-PC7, 0.5 ML ASR Anti-HLA-ABC-FITC, 2ML, ASR CD10-PC5, 1ML, ASR CD154 (CD40L)-PE, 2ML, ASR CD5-ECD, 0,5ml, ASR CD81-APC, 0.5 ML ASR IgG1(Mouse)-ECD, 1ML, ASR CD33-SNv428, 0.5 ML, ASR Anti-TCR Vbeta5.1-FITC, 1ML, ASR CD8-APC, 0.5 ML ASR Anti-TIA-1, 0.2MG, ASR CD38-PC5.5, 0.5 ML ASR CD64-FITC, 2ML, ASR CD127-APC-Alexa Fluor 750, 0.5 ML ASR CD13-ECD, 0.5 ML ASR CD48-ECD, 0.5 ML ASR CD20-SNv605, 0.5 ML ASR CD133-APC, 0.5 ML ASR CD2-ECD, 0,5 ml, ASR CD16-Pacific Blue, 0.5 ML ASR CD22-PC7, 1ML ASR IgG2a(Mouse)-FITC, 2ML ASR CD40-PC5.5, 0.5 ML ASR CD81-FITC, 1ML, ASR Anti-TCR Vbeta8-FITC, 1ML, ASR CD30-APC, 0.5 ML ASR IgG2a(Mouse)-PC7, 1ML, ASR CD41-PE, 2ML, ASR CD27-APC-Alexa Fluor 750, 0.5 ML ASR CD4-PE, 2ML, ASR CD13-APC, 0.5 ML ASR CD1c-PC5.5, 0,5 ml, ASR CD3-APC-Alexa Fluor 750, 0.5 ML ASR CD34-FITC, 2ML, ASR CD158f-PE, 1ML, ASR CD27 ECD, 0.5 ML ASR CD45-Alexa Fluor 647, 1ML, ASR CD44-PE, 2ML ASR CD80-APC, 0.5 ML ASR CD59-FITC, 2ML, ASR CD33-PC7, 1ML ASR IgG1(Mouse)-APC, 1ML, ASR CD158b1/b2,j-PC7, 0.5 ML ASR CD11b, 0.2MG, ASR CD1a-FITC, 1ML, ASR CD22-PC5.5, 0.5 ML ASR Anti-Granzyme B-FITC, 1 Ml, ASR CD13-PC7, 0.5 ML ASR CD71-FITC, 2ML, ASR Anti-TCR PAN alpha/beta-PE, 1ML ASR CD11c-PC5.5, 0.5 ML ASR CD21-Pacific Blue, 0.5 ML ASR CD117-PC5, 1ML, ASR CD58-PC5, 1ML, ASR CD45-Krome Orange, 1ML, ASR Anti-HLA-DR FITC, 2ML, ASR IgG1 (Mouse)-PC5.5, 1ML ASR CD66b-FITC, 2ML, ASR CD28-PC5.5, 0.5 ML ASR Anti-TCR Vbeta2-PE, 1ML, ASR CD64-Pacific Blue, 0.5 ML ASR CD15-Krome Orange, 0.5 ML ASR CD71-SNv428, 0.5 ML ASR CD4-PC5.5, 0.5 ML ASR CD11c-PC5, 1ML, ASR CD22-PE, 2ML, ASR CD103-FITC, 2ML, ASR IgG1(Mouse)-Pacific Blue, 1ML ASR CD21-FITC, 2ML, ASR Anti-Lambda-PE (Goat Polyclonal), 2Ml ASR CD7-PE, 2ML, ASR CD122-PC7, 1ML ASR CD38-Pacific Blue, 0.5 ML ASR CD38(VHH)-Alexa Fluor 700, 0.5 ML, ASR CD11b-PC7, 1ML ASR CD62L-FITC, 2ML, ASR CD85j (ILT2)-PE, 1ML ASR CD64-PE, 2ML, ASR CD158b1/b2,j-APC, 0.5 ML ASR CD14-PC5.5, 0.5 ML ASR Anti-TCR Vgamma9-PC5, 0.5 ML ASR CD8BETA-PE, 2ML, ASR CD24-APC-Alexa Fluor 750, 0.5 ML ASR Anti-ROR1-PE, 1ml, ASR CD33-PC5.5, 0.5 ML ASR CD14-PE, 2ML, ASR CD23-APC-Alexa Fluor 700, 0.5 ML ASR Anti-TNFalpha-Alexa Fluor 700, 0.5 Ml, ASR F:Anti-Kappa-FITC (Goat Polyclonal), 2ml ASR CD80-FITC, 2ML, ASR CD23-Pacific Blue, 0.5 ML ASR CD28, 0.2 MG, ASR CD5-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Vbeta20-FITC, 1ML, ASR CD16-FITC, 2ML, ASR Anti-TCR Valpha24-FITC, 1ML, ASR Anti-TCR Vbeta7-PE, 1ML, ASR Anti-Ki-67-Alexa Fluor 488, 0.5Ml ASR CD11c-PC7, 1ML, ASR CD166-PE, 2ML ASR CD5-APC-Alexa Fluor 700, 0.5 ML ASR CD83 FITC, 2ML, ASR CD55-FITC, 2ML, ASR CD23-SNv428, 0.5 ML, ASR CD25-APC-Alexa Fluor 700, 0.5 ML ASR CD64-PC5, 1ML, ASR CD4-SNv605, 0.5 ML, ASR CD25-SNv428, 0.5 Ml ASR CD48-FITC, 2ML, ASR CD11b-PC5 , 1ML, ASR Anti-TCR C-Beta-2 (TRBC2)-APC, 0.5 ML, ASR CD61-PC5.5, 0.5 ML ASR CD235a-FITC, 2ML, ASR CD94-APC, 0.5 ML ASR CD15-Pacific Blue, 0.5 ML ASR CD19-FITC, 2ML, ASR CD56-PC7, 1ML ASR CD2-PE, 2ML, ASR CD13-PC7, 1ML ASR CD27-SNv428, 0.5 ML ASR CD45-APC-Alexa Fluor 700, 1ML ASR CD3-APC, 1ML, ASR CD79b-PC5.5, 0.5 ML ASR CD123-PC5.5, 0.5 ML ASR CD99-ECD, 0.5 ML, ASR Anti-TCR Vbeta7.2-PE, 1ML, ASR CD117-PE, 2ML, ASR CD55-PE, 2ML, ASR CD40, 0.2 MG, ASR IgG1(Mouse)-Krome Orange, 1ML, ASR CD22-FITC, 2ML, ASR CD158f (KIR2DL5)-APC, 0.5 ML ASR CD80-PE, 2ML, ASR Anti-LACTOFERRIN-PE, 2ML, ASR CD62L-ECD, 1ML, ASR CD36-Pacific Blue, 0.5 ML, ASR CD83-PC5, 1ML, ASR Anti-TCR Vbeta21.3-FITC, 1ML, ASR CD11b-Pacific Blue, 0.5 ML ASR CD63-PE, 2ML, ASR CD56-APC, 1ML, ASR CD66b-APC-Alexa Fluor 750, 0.5 ML ASR CD16-ECD, 1ML ASR Anti-TCR Vbeta4-FITC, 1ML, ASR CD7-SNv650, 0.5 ML, ASR CD2-PC5, 1ML, ASR CD86 (B7-2)-APC-Alexa Fluor 750, 0.5 ML ASR Anti-TCR Vbeta11-APC, 0.5 ML ASR Anti-TCR Pan gamma/delta-FITC, 1ML, ASR Anti-TCR C-Beta-1 (TRBC1)-PE, 1 ML, ASR Anti-TCR Vdelta2-FITC, 1ML, ASR Anti-NG2-PE, 2ML, ASR CD90-PE, 2ML, ASR CD44-Pacific Blue, 0.5 ML ASR CD5-ECD, 1ML ASR CD13-PE, 2ML, ASR CD135-PE, 2ML, ASR CD28-PC7, 0.5 ML ASR CD10-APC , 1ML, ASR CD10-PE, 2ML, ASR CD117-PC7 , 1ML, ASR CD25-FITC, 2ML, ASR CD25-SNv605, 0.5 ML ASR ANTI-IL2-FITC, 1ML ASR Anti-Kappa-APC (Goat Polyclonal), 0.5Ml ASR CD206 (MMR)-PE, 2ML, ASR CD197 (CCR7)-PE, 1ML, ASR CD138-Pacific Blue, 0.5 ML ASR CS/CC T8-RD1/T4-FITC CS/CC T4-RD1/T8-FITC CC MsIg2b-RD1 CC MsIg2b-FITC CC MsIgG2b CS/CC MsIgG2b-FITC AQUIOS Flow-Count Fluorospheres AQUIOS Immuno-Trol Low Cells CS triCHROME CD45-FITC/CD56-RD1/CD3-PC5 CS/CC Mo2-RD1/KC56(T-200)-FITC CS CD3-FITC/CD56-RD1 CS/CC MsIgG1-RD1/ MsIgG1-FITC AQUIOS Sodium Hypochlorite Solution AQUIOS Cleaning Agent (PN B25698) DxH 500 Series Cleaner (PN 36868) DxH Cleaner AcT 5diff Rinse Flow Clean (PN A64669) CLENZ AQUIOS Cleaning Agent (PN C48097) Flow Clean (PN C48093) CS/CC CD3(IgG1)-FITC/T8-RD1 CS/CC CD3(IgG1)-FITC/B4-RD1 CC B4-FITC CS/CC B4-RD1 CC B4-RD1 CS/CC B4-FITC IMMUNO-TROL LOW CELLS PerFix NC Kit (Lysing Reagent) IRIS BODY FLUIDS LYSING REAGENT AQUIOS Lysing Reagent Kit Fixative Solution (10X) OptiLyse C : Lysing Solution Lysing Solution (10X) IntraPrep Reagent 2: Permeabilization IOTest 3 Fixative VersaLyse : Lysing Solution IOTest 3 Lyse DxH 500 Series Lyse (PN B36846) Whole Blood Lysing Reagent COULTER Rinsol Cleaning Agent DxH Cell Lyse 1L & 5L AcT 5diff Fix DxH Retic Pack IMMUNOPREP REAGENT DxH diff Pack AcT 5diff Hgb Lyse COULTER DxH Cell Lyse DxH ECO Cell Lyse (5L) AcT 5diff WBC Lyse Access Red Blood Cell Folate Lysing Agent DxH ECO Cell Lyse (1L) Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG) FlowCARE PLG CD4 Reagent Latron CP-X Control CS triCHROME MsIgG1-FITC/MsIgG1-RD1/MsIgG1-PC5 CYTO-COMP REAGENT CS triCHROME CD8-FITC/CD4-RD1/CD3-PC5 CS tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 CS triCHROME CD45-FITC/CD19-RD1/CD3-PC5 FLOW-SET CC Mo2-FITC CS/CC MsIgM-FITC CS/CC MY4-FITC CC MsIgM-FITC Isotypic Control CC MY4-FITC CS/CC MsIgM-RD1 CC MY4-RD1 CC Mo2-RD1 CS/CC Mo2-FITC CS/CC Mo2-RD1 CC MsIgM-RD1 Navios EX Offline ACQ Single User Software V2 Win 7 Navios EX TetraSoftware V2 New User Navios EX Flow Cytometer 8 Color/2 Laser Navios EX Flow Cytometer 6 Color/2Laser Navios EX Offline ACQ 5 Users Software V2 Win 7 Navios EX Acquisition New User Software V2 Win 7 Flow-Set Pro Flurospheres ClearLLab B2 (PN B66810) ClearLLab T2 (PN B66808) ClearLLab B1 (PN B66809) ClearLLab M (PN B66812) ClearLLab T1 (PN B66807) LeukoSure Enumeration Kit LeukoSure Fluorospheres ReticPrep Reagent Kit CS/CC T8-FITC CC T8-FITC CC T8-RD1 CS/CC T8-RD1 Cyto-Trol Control Cells ClearLLab 10C M2 Cell Tube (PN B96808) ClearLLab 10C T Cell Tube (PN B96806) ClearLLab 10C M1 Cell Tube (PN B96807) ClearLLab 10C B Cell Tube (PN B96805) ClearLLab Compensation Kit (PN B74074) Latron Control AQUIOS Sheath Solution (PN B25697) AQUIOS IMMUNO-TROL Low Cells (PN B25700) AQUIOS Tetra-2+ Panel (PN B23534) AQUIOS CL Flow Cytometer AQUIOS IMMUNO-TROL Cells (PN B23535) AQUIOS Tetra-1 Panel (PN B23533) AQUIOS Sodium Hypochlorite (PN B23536) AQUIOS Lysing Reagent Kit (PN B23538) CC CD3(IgG1)-FITC CC MsIgG1-FITC CS/CC MsIgG1-RD1 CS/CC CD3(IgG1)-FITC CC MsIgG1 Isotypic Control CS/CC MsIgG1-FITC CC CD3(IgG1)-RD1 CC MsIgG1-RD1 CS/CC CD3(IgG1)-RD1 CS/CC T11-RD1/B4-FITC Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395067) Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395261) Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395066) Hemoccult ICT Immunochemical Fecal Occult Blood Test Controls (PN 395068) Hemoccult ICT Immunochemical Fecal Occult Blood Test Collection Cards (PN 395065) Hemoccult SENSA Single Slides (PN A96636) CS/CC CD3(IgG1)-FITC/T4-RD1 CS/CC MsIgG2a-FITC CC MsIgG2a CC MsIgG2a-FITC CC MsIgG2a-RD1 CC T1-RD1 CS/CC MsIgG2a-RD1 IOTest CD3-PC7 IOTest CD8-ECD IOTest CD8-PC7 IOTest MsIgG1-PC7 IOTest CD4-PC7 AQUIOS PLG Panel 50 tests AQUIOS PLG Panel 400 tests LIN-X Linearity Control Manual CD4 Count Kit S-Cal Calibrator QuickCOMP 2 Kit QuickCOMP 4 Kit CS/CC T11-RD1/B1-FITC CS/CCMsIgG2a-FITC CS/CC T11-FITC CC T11-RD1 CS/CC T11-RD1 CC T11-FITC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2008-12-09
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2005-02-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2015-05-20
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
JCB	Detergent	Pathology	Class 1	864.4010	1977-12-14
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2012-09-11
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1977-12-14
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2017-06-27
PDX	Flow Cytometry Calibrator	Hematology	Class 2	864.5220	2017-06-27
PWD	Flow Cytometric Test System For Hematopoietic Neoplasms	Hematology	Class 2	864.7010	2017-06-30
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	Class 2	864.9650	2008-07-21
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07
GGL	Control, White-Cell	Hematology	Class 2	864.8625	2000-12-28
PWD	Flow Cytometric Test System For Hematopoietic Neoplasms	Hematology	Class 2	864.7010	2019-03-22
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-11
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2015-04-14
OYE	Flow Cytometric Reagents And Accessories.	Hematology	Class 2	864.5220	2015-04-14
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2010-04-29
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-13
JPK	Mixture, Hematology Quality Control	Hematology	Class 2	864.8625	2012-09-11
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-12
KRY	Calibrator For Platelet Counting	Hematology	Class 2	864.8175	2000-12-28
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2012-09-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BECKMAN COULTER, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

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Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3021394862	Beckman Coulter Biomedical GmbH	Baierbrunn Bavaria, DE
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K162333	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo One Step Fecal Occult Blood (FOB) Test	2017-05-14
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07
K781077	Dade, Baxter Travenol Diagnostics, Inc.	CONTROL, HEMATOLOGY, CH-60	1978-07-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0011-2014	Siemens Healthcare Diagnostics	2	ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts.
Z-0021-2013	Beckman Coulter Inc.	2	Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF).
Z-0033-2013	Beckman Coulter Inc.	2	CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013. Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1017835. Last updated year: 2026. Please use registration number 1017835 when referencing this establishment in official correspondence.