AWS WS3853

GUDID 05055273206982

This product should be used in conjunction with RX SERIES reagents to clean probes and cuvettes.

RANDOX LABORATORIES LIMITED

Wash/cleaning solution IVD, automated/semi-automated system
Primary Device ID05055273206982
NIH Device Record Key8b5a75ee-77ab-4e5a-9af7-60257dfb1ee2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAWS
Version Model NumberWS3853
Catalog NumberWS3853
Company DUNS227530649
Company NameRANDOX LABORATORIES LIMITED
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

Customer Support Contacts

Phone+44289445170
Emailtechnical.services@randox.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Once opened the reagent is stable for 1 month on board the analyser at approximately +10ºC

Device Identifiers

Device Issuing AgencyDevice ID
GS105055273206982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJFAnalyzer, Chemistry, Micro, For Clinical Use

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 Date2016-09-26

On-Brand Devices [AWS]

05055273214529This product should be used in conjunction with RX daytona plus reagents to clean probes and cuv
05055273206982This product should be used in conjunction with RX SERIES reagents to clean probes and cuvettes.

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