Duns Number:251005005
Device Description: Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detectio Rapid Response hCG Pregnancy Test Strips - 100 tests/ kit are for the qualitative detection of Human Chorionic Gonadotropin in urine/ serum.
Catalog Number
HCG-3S100
Brand Name
Rapid Response
Version/Model Number
HCG-3S100
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132834,K132834
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
5ca1e60d-eacd-44a9-97d6-bd7a5a1fe906
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 25, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |