Duns Number:089138159
Device Description: FPPL Premier Value SPS +/- Blue Cap
Catalog Number
-
Brand Name
Premier Value
Version/Model Number
One Step Pregnancy Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 09, 2022
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
K042280,K042280
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
321df3f8-b1f3-4d45-a80b-b82c48eda7cf
Public Version Date
August 10, 2022
Public Version Number
2
DI Record Publish Date
September 21, 2020
Package DI Number
10840986036993
Quantity per Package
24
Contains DI Package
00840986036996
Package Discontinue Date
August 09, 2022
Package Status
Not in Commercial Distribution
Package Type
Shipping Case
| 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. | 5 |