Duns Number:006959555
Device Description: One-step ovulation predictor test used for the detection of Luteininzing Hormone (LH) in u One-step ovulation predictor test used for the detection of Luteininzing Hormone (LH) in urine to predict your time of ovulation.
Catalog Number
-
Brand Name
MEIJER OVULATION TEST - EASY ONE STEP
Version/Model Number
16919
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CEP
Product Code Name
Radioimmunoassay, Luteinizing Hormone
Public Device Record Key
0cb7c7da-c207-4a14-85be-5532849e7a1e
Public Version Date
July 18, 2018
Public Version Number
4
DI Record Publish Date
July 22, 2016
Package DI Number
10760236136191
Quantity per Package
24
Contains DI Package
00760236169192
Package Discontinue Date
-
Package Status
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |