Catalog Number

PBCard-01-BAR300

Brand Name

Premier Bio-Cup & Bio-Dip

Version/Model Number

PBCard-01-BAR300

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

DIS

Product Code Name

Enzyme Immunoassay, Barbiturate

Public Device Record Key

f5745d6b-56e0-46f1-945c-4eef5981cf92

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

-