Primary Device ID | 15099590638191 |
NIH Device Record Key | 8dbce4ae-c24d-41eb-9693-2d60563ca6e8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PrepPlus 2 |
Version Model Number | 378600 |
Catalog Number | 378600 |
Company DUNS | 008254708 |
Company Name | Beckman Coulter, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 15099590638191 [Primary] |
PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-23 |
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 |
15099590745165 - ACCESS HIV Ag/Ab combo Calibrators | 2024-03-25 The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitati |
15099590745172 - ACCESS HIV Ag/Ab combo QC | 2024-03-25 The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV |
15099590793005 - MicroScan | 2024-03-25 DVD, LabPro V4_V5 Maintenance Update 05 |