AUTION™ Sticks 9EB Test Strips

GUDID 00015482736279

Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.

ARKRAY USA, INC.

Urine analyser IVD, laboratory
Primary Device ID00015482736279
NIH Device Record Key6dfc7a1d-ec29-4b75-acb3-fb0095f090d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTION™ Sticks 9EB Test Strips
Version Model Number73627
Company DUNS008171162
Company NameARKRAY USA, INC.
Device Count100
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx
Phone+1(877)538-8872
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482736279 [Primary]
GS150015482736274 [Unit of Use]

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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-09-16
Device Publish Date2016-09-23

Devices Manufactured by ARKRAY USA, INC.

00015482117313 - AUTION MAX™ AX-4060 Analyzer2024-12-10 The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis sytem intend
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/L2024-12-10 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]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUTION
AUTION
79384190 not registered Live/Pending
ARKRAY, Inc.
2023-08-21
AUTION
AUTION
79346928 not registered Live/Pending
ARKRAY, Inc.
2022-03-23
AUTION
AUTION
75520515 2713700 Live/Registered
ARKRAY, INC.
1998-07-17

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