Duns Number:227530649
Device Description: For the quantitative in vitro determination of total protein in urine and C.S.F.
Catalog Number
-
Brand Name
TOTAL PROTEIN (UP)
Version/Model Number
UP1570
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
-
Product Code
JIR
Product Code Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Public Device Record Key
9b55802f-2e16-4368-851b-6c6e01799d8c
Public Version Date
October 13, 2022
Public Version Number
1
DI Record Publish Date
October 05, 2022
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |