Duns Number:007941230
Device Description: Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made With Natural Kit Human Chorionic Gonadotropin Pregnancy Test Urine/Serum 25-Test Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
MC02SU
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
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
-
Product Code
JHI
Product Code Name
Visual, pregnancy hCG, prescription use
Public Device Record Key
2351a4ae-4fb5-4688-94c5-56dd83488084
Public Version Date
February 21, 2019
Public Version Number
5
DI Record Publish Date
August 29, 2016
Package DI Number
50885632116306
Quantity per Package
10
Contains DI Package
10885632116308
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |