Duns Number:092519016
Device Description: DRUGS OF ABUSE QC LEVEL 2
Catalog Number
-
Brand Name
DRUGS OF ABUSE QC LEVEL 2
Version/Model Number
DA QC 2 OF PM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
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
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
8803119f-07b1-4f75-bcdf-e8c7a5d8dbc2
Public Version Date
July 06, 2022
Public Version Number
1
DI Record Publish Date
June 28, 2022
Package DI Number
B80003716500081
Quantity per Package
4
Contains DI Package
B80003716500080
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 113 |