Duns Number:106793995
Device Description: Quick-Read Precision Grid Urinalysis Slide with Counting Grid, 10 Wells/Slide, 100 Slides/ Quick-Read Precision Grid Urinalysis Slide with Counting Grid, 10 Wells/Slide, 100 Slides/Box (1000 Tests)
Catalog Number
-
Brand Name
Globe Scientific
Version/Model Number
3800
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
KEW
Product Code Name
Slides, Microscope
Public Device Record Key
a8ad41b4-b9c0-4dc6-9598-cc5eead885f8
Public Version Date
December 04, 2019
Public Version Number
1
DI Record Publish Date
November 26, 2019
Package DI Number
00840095606073
Quantity per Package
10
Contains DI Package
00840095606066
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 184 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |