Duns Number:007914906
Device Description: A convenience kit consisting of 10 Ovulation Test devices and 1 One-Step Pregnancy Test.
Catalog Number
-
Brand Name
Good Neighbor Pharmacy
Version/Model Number
Early Ovulation Test
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2022
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
e6466ed9-bd1a-4ebe-a7cb-f579ff51b37b
Public Version Date
August 08, 2022
Public Version Number
3
DI Record Publish Date
November 11, 2020
Package DI Number
10087701433631
Quantity per Package
24
Contains DI Package
00087701433634
Package Discontinue Date
June 13, 2022
Package Status
Not in Commercial Distribution
Package Type
Shipping Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |