Duns Number:849098897
Device Description: 20+50 Strip Combo; 20 hCG Pregnancy Test + 50 LH Ovulation Test
Catalog Number
-
Brand Name
Preview
Version/Model Number
PRE-H20L50
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
b2b8130c-aaf3-4f4d-98f0-0cc02abcb6de
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 24, 2020
Package DI Number
10816862022466
Quantity per Package
60
Contains DI Package
00816862022469
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 1 |