Duns Number:045361136
Device Description: A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
Catalog Number
1430-003
Brand Name
TRUE® 20 Sample Pack
Version/Model Number
1430-003
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JHI
Product Code Name
Visual, Pregnancy Hcg, Prescription Use
Public Device Record Key
cc59a3db-9586-433f-a226-b1d855732ef5
Public Version Date
June 15, 2018
Public Version Number
1
DI Record Publish Date
May 15, 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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |