Duns Number:080641505
Device Description: Zacurate Combined Pregnancy Kit - 60 Ovulation strip + 20 Pregnancy strips
Catalog Number
M490N-CBAA-EGZA
Brand Name
Zacurate
Version/Model Number
M490N-CBAA-EGZA
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
NGE
Product Code Name
Test, Luteinizing Hormone (Lh), Over The Counter
Public Device Record Key
8d8f3409-0e77-4222-bc7e-69c2bcbdecaa
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 29, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |