Duns Number:008028248
Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC Immunoassay for the detection of the following drug substance(s) in human urine: AMP / COC / OPI / PCP / THC
Catalog Number
07RD7064-01
Brand Name
DOA 5 PANEL TEST
Version/Model Number
07RD7064-01
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
DKZ
Product Code Name
ENZYME IMMUNOASSAY, AMPHETAMINE
Public Device Record Key
4d8319ec-1d2b-4fd5-bde7-5ad892284787
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
October 20, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 250 |
| U | Unclassified | 1 |