Duns Number:010118759
Device Description: AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50
Catalog Number
PBCup-10-20
Brand Name
Premier Bio-Cup & Bio-Dip
Version/Model Number
PBCup-10-20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2080
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122809,K122809
Product Code
DIO
Product Code Name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Public Device Record Key
526d04b6-070a-4a40-b092-18d1172d4c8f
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
September 25, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-