Duns Number:075150847
Device Description: This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urin This is a test for the qualitative detection of human Chorionic Gonadotropin (HCG) in urine.
Catalog Number
RAP-2822
Brand Name
HCG midstream Test
Version/Model Number
RAP-2822
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K980532
Product Code
LCX
Product Code Name
KIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
Public Device Record Key
d495889b-bb8e-40c3-ba0d-c262ed835e58
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
March 20, 2019
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 |
|---|---|---|
| 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. | 32 |