UA Win10 Kit C52900

GUDID 15099590735982

Urinalysis Win10 Kit with PC7 hardware

BECKMAN COULTER IRELAND INC.

Urine analyser IVD, laboratory, automated Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory Urine analyser IVD, laboratory
Primary Device ID15099590735982
NIH Device Record Keyc1ee39b1-9547-47e9-b04a-52243b9f8e14
Commercial Distribution StatusIn Commercial Distribution
Brand NameUA Win10 Kit
Version Model NumberC52900
Catalog NumberC52900
Company DUNS985071975
Company NameBECKMAN COULTER IRELAND INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115099590735982 [Primary]

FDA Product Code

KQOAutomated Urinalysis System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-30
Device Publish Date2020-03-20

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.