Catalog Number

PBCup-10-04

Brand Name

Premier Bio-Cup & Bio-Dip

Version/Model Number

PBCup-10-04

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

ca185433-56b3-490e-8be6-c3d0a51ef7d8

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

-