Catalog Number

4512944190

Brand Name

Amphetamines II

Version/Model Number

4512944190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2018

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K083764

Product Code

DKZ

Product Code Name

ENZYME IMMUNOASSAY, AMPHETAMINE

Public Device Record Key

73a0caf1-3a45-4b17-88a9-6e5bc9d60e56

Public Version Date

November 11, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-