PrepPlus 2 378600

GUDID 15099590638191

COULTER PrepPlus 2

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD
Primary Device ID15099590638191
NIH Device Record Key8dbce4ae-c24d-41eb-9693-2d60563ca6e8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrepPlus 2
Version Model Number378600
Catalog Number378600
Company DUNS008254708
Company NameBeckman Coulter, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590638191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Beckman Coulter, Inc.

15099590575243 - Access hLH2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing
15099590760823 - Access NT-proBNP2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term
15099590760830 - ACCESS NT-proBNP CALIBRATORS2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
15099590772840 - Access Ferritin2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti
15099590745158 - ACCESS HIV Ag/Ab combo2024-03-25 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 Calibrators2024-03-25 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 QC2024-03-25 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 - MicroScan2024-03-25 DVD, LabPro V4_V5 Maintenance Update 05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.