Duns Number:064608573
Device Description: ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect t ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.
Catalog Number
A2191B16
Brand Name
Albustix® Reagent Strips
Version/Model Number
10333485
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
K992257,K992257
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
819ef18f-3813-4a41-b439-2576db12c4ad
Public Version Date
November 19, 2021
Public Version Number
5
DI Record Publish Date
September 24, 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 | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |