Catalog Number

9F129UL

Brand Name

Syva® Emit® II Plus Benzodiazepine Assay

Version/Model Number

10445431

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

K993985

Product Code

JXM

Product Code Name

Enzyme immunoassay, benzodiazepine

Public Device Record Key

d8c022f1-4b0f-4aa1-b02f-71994d93a8da

Public Version Date

November 18, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-