AQUIOS Tetra-1 Panel B23533

GUDID 15099590225704

AQUIOS Tetra-1 Panel CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5

BECKMAN COULTER IRELAND INC.

Multiple CD cell marker IVD, antibody
Primary Device ID15099590225704
NIH Device Record Key9aba8798-db11-4e22-9513-033ada130fad
Commercial Distribution StatusIn Commercial Distribution
Brand NameAQUIOS Tetra-1 Panel
Version Model NumberB23533
Catalog NumberB23533
Company DUNS985071975
Company NameBECKMAN COULTER IRELAND 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS115099590225704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYEFlow Cytometric Reagents And Accessories.

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 IRELAND INC.

10837461002031 - iQ®200 2023-10-13 iQ Precision Kit
10837461002147 - iQ®200 2023-10-13 iQ® Calibrator Pack
10837461002178 - iQ®200 2023-10-13 iQ® Control/Focus Set (NA/INTL)
10837461002239 - Iris®2023-10-13 Iris® Diluent Pack (NA)
10837461002260 - Iris®2023-10-13 Iris® System Cleanser Pack (NA/INTL)
10837461002307 - iQ®200 2023-10-13 iQ® Body Fluids Lysing Reagent (NA/INTL)
10837461002345 - iQ®200 2023-10-13 iQ® Body Fluids Controls-Level I and Level II (NA/INTL)
10837461002376 - iQ®200 2023-10-13 iQ® Lamina™ Case of 2 x 7 L

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