Duns Number:080651010
Device Description: HCG Pregnancy Test Strip -3.5mm
Catalog Number
-
Brand Name
PreKnow
Version/Model Number
21100015410508
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
98efcb77-75f7-4aa5-9a8d-49f61051a7e0
Public Version Date
September 03, 2018
Public Version Number
1
DI Record Publish Date
August 02, 2018
Package DI Number
00857275007452
Quantity per Package
100
Contains DI Package
00857275007544
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |