PC7 Setup Kit 737664

GUDID 15099590250676

PC7 (770/488) Setup Kit

Beckman Coulter, Inc.

Non-blood cell primer/calibrator/control material IVD, reagent Non-blood cell primer/calibrator/control material IVD, reagent
Primary Device ID15099590250676
NIH Device Record Key9c4680b6-a264-46d5-855c-85bd5e234aaa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePC7 Setup Kit
Version Model Number737664
Catalog Number737664
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590250676 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-15

Devices Manufactured by Beckman Coulter, Inc.

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
15099590780982 - Access Free T42024-03-20 The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thy
15099590752682 - Access Progesterone II2024-03-11 The Access Progesterone II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of
15099590752699 - Access Progesterone II Calibrators2024-03-11 The Access Progesterone II Calibrators are intended to calibrate the Access Progesterone II assay for the quantitative determina

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