Duns Number:045623154
Device Description: Pointe Scientific, Inc. Total Protein Reagent is for the quantitative determination of tot Pointe Scientific, Inc. Total Protein Reagent is for the quantitative determination of total protein concentration in serum. Packaged for use on Olympus Analyzers. 6 x 66ml, 6 x 30ml
Catalog Number
OT928-576
Brand Name
Pointe Scientific, Inc. Total Protein
Version/Model Number
OT928-576
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K822468
Product Code
CEK
Product Code Name
Biuret (Colorimetric), Total Protein
Public Device Record Key
a3c174a2-f9f8-48e4-bdbb-e6873d154361
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |