Duns Number:080028910
Device Description: Reagent strips for urinalysis - glucose. 50 test strips.
Catalog Number
2806
Brand Name
DIASTIX®
Version/Model Number
2806
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K831600,K831600,K831600,K831600
Product Code
JIL
Product Code Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Public Device Record Key
f2624764-af8b-474a-8322-6870d6cfed84
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
40301932806509
Quantity per Package
24
Contains DI Package
00301932806501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipper/case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |
| 3 | A medical device with high risk that requires premarket approval | 2 |