Navios tetra Software 775213

GUDID 15099590510756

Navios tetra Software

BECKMAN COULTER IRELAND INC.

Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD Laboratory instrument/analyser application software IVD
Primary Device ID15099590510756
NIH Device Record Key0eb39987-e48a-4c90-9306-89b01c408463
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavios tetra Software
Version Model Number775213
Catalog Number775213
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 Usefalse
Lot Batchfalse
Serial Numberfalse
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
GS115099590510756 [Primary]

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 Number2
Public Version Date2018-03-29
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.