| Primary Device ID | 00816068020290 |
| NIH Device Record Key | e6f7dd73-d690-4c49-aedb-c6e9fa68c252 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 |
| Version Model Number | 3LA085 |
| Catalog Number | 3LA085 |
| Company DUNS | 125006353 |
| Company Name | ADVANCED INSTRUMENTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com | |
| Phone | +17813209000 |
| Orders@aicompanies.com |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00816068020290 [Primary] |
| JMZ | Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-29 |
| Device Publish Date | 2020-09-21 |
| 00816068020535 - Advanced Instruments RBC Reagent Filtration Kit | 2021-05-31 The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance crite |
| 00816068020290 - Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 | 2020-09-29Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Renol urine controls are formulated to mimic reportable ranges (low-to-high levels) for urine. |
| 00816068020290 - Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 | 2020-09-29 Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used |
| 00816068020351 - Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9 | 2020-09-29 Protinol protein-based osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls m |
| 00816068020481 - Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10 | 2020-09-29 The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and f |
| 00816068020504 - Advanced Instruments Ease-Eject 20-Microliter Sampler | 2020-09-29 Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or |
| 00816068020542 - Advanced Instruments Osmo1® Single-Sample Micro-Osmometer | 2020-09-29 With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of |
| 00816068020559 - Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer | 2020-09-29 Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel desig |
| 00816068020566 - Advanced Instruments 30 µL Pipet | 2020-09-29 Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers |