Duns Number:788124873
Device Description: Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, indiv Human Chorionic Gonadotropin (HCG) test kit, over the counter, FDA product code LCX, individual tests in pouches; 50 tests per box. Market--physician office.
Catalog Number
-
Brand Name
R Med Pregnancy Test Cassettes
Version/Model Number
C1001C-a
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
cdb86510-5201-4b85-80f2-677ac327774c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 13, 2017
Package DI Number
B49754210021001CA11
Quantity per Package
50
Contains DI Package
B497542100C1001CA1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |