Duns Number:125006353
Device Description: Renol urine osmolality controls are intended for use in evaluating the performance of cust Renol 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.
Catalog Number
3LA085
Brand Name
Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8
Version/Model Number
3LA085
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JMZ
Product Code Name
Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
Public Device Record Key
e6f7dd73-d690-4c49-aedb-c6e9fa68c252
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 50 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |