AUTION EYE™ Calibrator Focus/Calibrator
GUDID 00015482181598
AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
ARKRAY USA, INC.
Urine analyser IVD, laboratory| Primary Device ID | 00015482181598 |
| NIH Device Record Key | 4f6857e9-8e25-4e75-b311-85977943199e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUTION EYE™ Calibrator Focus/Calibrator |
| Version Model Number | 108159 |
| Company DUNS | 008171162 |
| Company Name | ARKRAY USA, INC. |
| Device Count | 1 |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00015482181598 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232416
FDA Product Code
| KQO | Automated Urinalysis System |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-10 |
| Device Publish Date | 2024-12-02 |
Devices Manufactured by ARKRAY USA, INC.
| 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 | 2024-12-10 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 | 2024-12-10AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510. |
| 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 |
Trademark Results [AUTION EYE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUTION EYE 79407848 not registered Live/Pending |
ARKRAY, Inc. 2024-08-05 |
 AUTION EYE 79278784 not registered Live/Pending |
ARKRAY, Inc. 2019-08-21 |
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