Duns Number:849098897
Device Description: 1-Midstreams; hCG Pregnancy Midstream Test Retail Box 1 Pcs Preview 10 MIU
Catalog Number
-
Brand Name
Preview
Version/Model Number
HCG-PRE-OTC10
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
K150022,K150022
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
0db50721-afe8-460e-97c3-dfdf291d8e6c
Public Version Date
October 31, 2022
Public Version Number
2
DI Record Publish Date
December 28, 2019
Package DI Number
10816862022176
Quantity per Package
140
Contains DI Package
00816862022179
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 |