Duns Number:117568595
Device Description: ONE STEP PREGNANCY TEST
Catalog Number
-
Brand Name
NEW CHOICE PLUS
Version/Model Number
00111
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
K984075
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
05dce266-c033-461a-b21a-b22158d8f661
Public Version Date
May 13, 2022
Public Version Number
1
DI Record Publish Date
May 05, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |