Duns Number:834472680
Device Description: Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Speci Tanner Scientific 10SG, 100/BTL, CLIA WAIVED, Tests for: Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocyte Esterase
Catalog Number
TNR 10SG
Brand Name
Tanner Scientific®
Version/Model Number
TNR 10SG
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
CDM
Product Code Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Public Device Record Key
5c0f001f-c048-4b0f-bd49-f89eb245b0cd
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
August 15, 2016
Package DI Number
10850011007140
Quantity per Package
100
Contains DI Package
00850011007143
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |