Duns Number:125006353
Device Description: Protinol protein-based osmolality controls are intended for use in evaluating the performa Protinol protein-based 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. Protinol protein-based controls are formulated to mimic reportable ranges (low-to-high levels) for human serum.
Catalog Number
3MA028
Brand Name
Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9
Version/Model Number
3MA028
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
cd240adb-5579-4fe4-85c7-defff5a538be
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 |