AUTION EYE™ Control Solution H/L

GUDID 00015482181574

AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION EYE AI-4510.

ARKRAY USA, INC.

Urine analyser IVD, laboratory
Primary Device ID00015482181574
NIH Device Record Key45cbb390-c9ab-47e8-8128-314797b44014
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTION EYE™ Control Solution H/L
Version Model Number108157
Company DUNS008171162
Company NameARKRAY USA, 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx
Phone1-855-646-3108
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482181574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-12-10
Device Publish Date2024-12-02

Devices Manufactured by ARKRAY USA, INC.

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00015482117344 - AUTION™ Sticks 9EB - Test Strips2024-12-10 AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following ana
00015482181550 - AUTION EYE™ Sheath Solution - 10L Bottle2024-12-10 AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed parti
00015482181574 - AUTION EYE™ Control Solution H/L2024-12-10AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION EYE AI-4510.
00015482181574 - AUTION EYE™ Control Solution H/L2024-12-10 AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the
00015482181598 - AUTION EYE™ Calibrator Focus/Calibrator2024-12-10 AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
00015482188627 - AUTION EYE™ AI-4510 Analyzer2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use.
14987486005299 - Concentrated Washing Solution 32024-12-10 A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated ins
00015482183103 - SPOTCHEM™ EZ Analyzer2024-05-31 Dry Chemistry Analyzer IVD, semi-automated

Trademark Results [AUTION EYE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUTION EYE
AUTION EYE
79407848 not registered Live/Pending
ARKRAY, Inc.
2024-08-05
AUTION EYE
AUTION EYE
79278784 not registered Live/Pending
ARKRAY, Inc.
2019-08-21

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