Primary Device ID | 10873037000070 |
NIH Device Record Key | 7ec9f7df-8829-4bf8-b988-25b276f2f360 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cytofuge |
Version Model Number | X00-003066-001 |
Company DUNS | 008254708 |
Company Name | Beckman Coulter, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10873037000070 [Primary] |
IFB | Cytocentrifuge |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-01 |
Device Publish Date | 2020-08-24 |
15099590762889 - Stem-Kit Reagents | 2024-11-04 Stem-Kit Reagents |
15099590762896 - StemTrol Control Cells | 2024-11-04 StemTrol Control Cells |
15099590732103 - DxI 9000 Access Immunoassay Analyzer | 2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali |
15099590575243 - Access hLH | 2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing |
15099590760823 - Access NT-proBNP | 2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term |
15099590760830 - ACCESS NT-proBNP CALIBRATORS | 2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te |
15099590772840 - Access Ferritin | 2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti |
15099590745158 - ACCESS HIV Ag/Ab combo | 2024-03-25 The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vi |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CYTOFUGE 74535105 1948107 Live/Registered |
BECKMAN COULTER, INC. 1994-06-08 |