Premier Bio-Cup & Bio-Dip - AMP500/COC150/OPI300/OXY100 - PREMIER BIOTECH, INC

Duns Number:010118759

Device Description: AMP500/COC150/OPI300/OXY100

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More Product Details

Catalog Number

PBCup-04-13

Brand Name

Premier Bio-Cup & Bio-Dip

Version/Model Number

PBCup-04-13

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 2080

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Device Record Status

Public Device Record Key

0fb2ed64-7587-4212-8ecb-8326827b4710

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

January 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-