Duns Number:080349866
Device Description: FPPL Signature Care SPS +/- (ER)
Catalog Number
-
Brand Name
Signature Care
Version/Model Number
One Step Pregnancy Test
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
K042280,K042280
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
f508235d-7531-442d-a827-6f72402103c9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 2016
Package DI Number
10021130788368
Quantity per Package
24
Contains DI Package
00021130788361
Package Discontinue Date
-
Package Status
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |