Duns Number:080349866
Device Description: CB8 Digital Pregnancy Stick Signature Care DPS Digital Early
Catalog Number
-
Brand Name
Signature Care
Version/Model Number
Digital Pregnancy Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 02, 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
K060128,K060128,K060128
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
61ef4bc2-58c8-4039-b4ec-baf725122b93
Public Version Date
February 03, 2022
Public Version Number
4
DI Record Publish Date
October 26, 2016
Package DI Number
10021130790057
Quantity per Package
24
Contains DI Package
00021130790050
Package Discontinue Date
February 02, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |