Catalog Number

9R029UL

Brand Name

Syva Emit II Plus 6-Acetylmorphine Assay

Version/Model Number

10730975

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102779

Product Code

DJG

Product Code Name

Enzyme immunoassay, opiates

Public Device Record Key

9617ab80-0c3b-4428-813a-9fc038565623

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

November 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-