Catalog Number

09014977190

Brand Name

Elecsys Syphilis

Version/Model Number

09014977190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K211302

Product Code

LIP

Product Code Name

ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Public Device Record Key

0b51c0ee-f5da-4aae-95a7-6cbc516007b0

Public Version Date

March 23, 2022

Public Version Number

1

DI Record Publish Date

March 15, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-