Duns Number:797393659
Device Description: ACCUTEST Drug Test Cup 11-Panel CLIA-WaivedAMP 1000, BAR 300, BZO 300, COC 300, MAD 300, M ACCUTEST Drug Test Cup 11-Panel CLIA-WaivedAMP 1000, BAR 300, BZO 300, COC 300, MAD 300, MET 1000, OPI 2000, OXY, PCP 25, TCA 1000 ,THC 50
Catalog Number
-
Brand Name
ACCUTEST Drug Test Cup 11-Panel CLIA-Waived
Version/Model Number
DS811
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071489,K071489
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
c8bbffd3-5f3e-4213-9d1d-a51b6292a041
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |