Duns Number:545868502
Device Description: The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3 The convenience kit is consisiting of 50 ovulation test 3mm strips and 20 pregnancy test 3mm strips .
Catalog Number
-
Brand Name
AFAC One Step HCG and Ovulation Urine test Kit
Version/Model Number
82238
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OIE
Product Code Name
Urine Collection Kit (Excludes Hiv Testing)
Public Device Record Key
ca7e5fe2-c1dd-4dbb-82d4-e1706fe0a98c
Public Version Date
July 26, 2019
Public Version Number
1
DI Record Publish Date
July 18, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |
| U | Unclassified | 1 |