Duns Number:827033924
Catalog Number
-
Brand Name
Clinical Guard
Version/Model Number
Pregnancy Urine Test Strip Pack of 50
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
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
58ee2cf8-06d2-4ae2-883a-0950386fa5d5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 19, 2017
Package DI Number
10897429002831
Quantity per Package
100
Contains DI Package
00897429002834
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |