Duns Number:072943876
Device Description: CB8 Digital Pregnancy Stick Topcare DPS Digital Early US
Catalog Number
-
Brand Name
Topcare Digital Pregnancy Test
Version/Model Number
CB8
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2019
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
1ab521f3-69c1-4a0b-a14f-178dd6e4a9c8
Public Version Date
December 03, 2019
Public Version Number
5
DI Record Publish Date
June 30, 2016
Package DI Number
10036800163215
Quantity per Package
24
Contains DI Package
00036800163218
Package Discontinue Date
December 02, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |