Catalog Number

04618858190

Brand Name

Elecsys Toxo IgM

Version/Model Number

04618858190

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

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

K162678

Product Code

LGD

Product Code Name

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Public Device Record Key

2bc68d09-15e9-4352-a6cb-9140ad3d04ad

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-