Primary Device ID | 15099590659561 |
NIH Device Record Key | 14a1eb3d-dd49-42f9-82e2-fcdac768e8bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MicroScan PROMPT |
Version Model Number | B1026-10D |
Company DUNS | 008254708 |
Company Name | Beckman Coulter, Inc. |
Device Count | 60 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 | 05099590659564 [Unit of Use] |
GS1 | 15099590659561 [Primary] |
LIE | Reagent/Device, Inoculum Calibration |
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 |
15099590209636 - DxH | 2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and |
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 |