Duns Number:008171162
Device Description: Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine.
Catalog Number
-
Brand Name
AUTION™ Sticks 10EA Test Strips
Version/Model Number
73526
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
K160062,K160062
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
7b676fcc-441b-4923-a0ae-acb206271d9f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 03, 2017
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |