Duns Number:543270668
Device Description: HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human c HIGHTOP Pregnancy Rapid Test Cassette is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy.
Catalog Number
-
Brand Name
ZiQ
Version/Model Number
Cassette
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
K192123,K192123,K192123
Product Code
LCX
Product Code Name
Kit, Test, Pregnancy, Hcg, Over The Counter
Public Device Record Key
4b366535-fa5d-4964-9d04-3aa9947d3124
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 2022
Package DI Number
16935091670003
Quantity per Package
12
Contains DI Package
06935091670006
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box