Duns Number:031802328
Device Description: 14 Panel DOA Test clear Cup;+Adulterant Test StripsOXI/SG/pH
Catalog Number
DOAY-1145A3
Brand Name
Healgen
Version/Model Number
DOAY-1145A3
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
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
05ddf7d4-10b7-461c-bdf1-b3f1e6faf2ae
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
July 29, 2019
Package DI Number
20816490022866
Quantity per Package
4
Contains DI Package
10816490022869
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 240 |