Duns Number:062312574
Device Description: A convenience kit consisting of 10 Ovulation Test devices and 1 One Step Pregnancy Test.
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
Early Ovulation Test Kit
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
K042280,K981271,K042280,K981271
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
4255e9b9-afd1-4bd0-a56e-c6c303cafb4d
Public Version Date
June 17, 2019
Public Version Number
1
DI Record Publish Date
June 07, 2019
Package DI Number
10050428605865
Quantity per Package
48
Contains DI Package
00050428605868
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |