Duns Number:080349866
Device Description: Signature Care Pregnancy 1ct Visual Blue Cap
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
a85e6b1d-6c57-4195-810f-9bec1ee1010f
Public Version Date
April 26, 2021
Public Version Number
1
DI Record Publish Date
April 16, 2021
Package DI Number
10021130163820
Quantity per Package
24
Contains DI Package
00021130163823
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 |