Duns Number:102672008
Device Description: Over-the-counter, One Step human Chorionic Gonadotropin hCG. Colloidal Gold Urine Pregnanc Over-the-counter, One Step human Chorionic Gonadotropin hCG. Colloidal Gold Urine Pregnancy. for in vitri diagnostic use only IVD. Test kit , midstream
Catalog Number
-
Brand Name
Clarisse
Version/Model Number
Midstream
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183097
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
f9b9b323-71a9-44fe-b4e8-d896e5ec6a93
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 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. | 3 |