| Primary Device ID | 14987486005299 |
| NIH Device Record Key | 9d9c9233-9f2f-49be-b82c-d8b329a74b1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Concentrated Washing Solution 3 |
| Version Model Number | 101687 |
| 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 |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| xxx@xxx.xxx | |
| Phone | +81748866833 |
| 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 | 04987486005292 [Primary] |
| GS1 | 14987486005299 [Package] Contains: 04987486005292 Package: Case Pack [6 Units] In Commercial Distribution |
| 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 | 2024-12-10 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 | 2024-12-10A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. |
| 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 |