Duns Number:008028248
Device Description: Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC / M-AMP / MTD / OPI-II/ PCP / THC
Catalog Number
07RD7071-02A
Brand Name
DOA 8 PANEL TEST
Version/Model Number
07RD7071-02A
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
DJG
Product Code Name
ENZYME IMMUNOASSAY, OPIATES
Public Device Record Key
085cf0e6-3462-491f-9c90-74ae4e2b8bf2
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 |