Duns Number:035967806
Device Description: AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)
Catalog Number
-
Brand Name
Noble Dip Card with AD (Urine)
Version/Model Number
E-NMCardA-10-51-BT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
June 30, 2080
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
-
Product Code
PUX
Product Code Name
Test, Amphetamine, Employment And Insurance Testing, Exempt
Public Device Record Key
b34d08ae-bbac-43b3-8364-d4fac51005a9
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
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. | 37 |