Primary Device ID | 00015482117344 |
NIH Device Record Key | e10b9737-8f6a-4f7d-9746-c39cb3126a09 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AUTION™ Sticks 9EB - Test Strips |
Version Model Number | 110734 |
Company DUNS | 008171162 |
Company Name | ARKRAY USA, INC. |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx | |
Phone | 1-855-646-3108 |
xxx@xxx.xxx |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Storage Environment Temperature | Between 1 Degrees Celsius and 30 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00015482117344 [Primary] |
GS1 | 50015482117349 [Unit of Use] |
KQO | Automated Urinalysis System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-12-10 |
Device Publish Date | 2024-12-02 |
00015482117313 - AUTION MAX™ AX-4060 Analyzer | 2024-12-10 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 Strips | 2024-12-10AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. |
00015482117344 - AUTION™ Sticks 9EB - Test Strips | 2024-12-10 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 Bottle | 2024-12-10 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/L | 2024-12-10 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/Calibrator | 2024-12-10 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 Analyzer | 2024-12-10 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 3 | 2024-12-10 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 Analyzer | 2024-05-31 Dry Chemistry Analyzer IVD, semi-automated |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUTION 79384190 not registered Live/Pending |
ARKRAY, Inc. 2023-08-21 |
AUTION 79346928 not registered Live/Pending |
ARKRAY, Inc. 2022-03-23 |
AUTION 75520515 2713700 Live/Registered |
ARKRAY, INC. 1998-07-17 |