Catalog Number

LSYCM

Brand Name

IMMULITE® Systems SYP CONTROL Syphilis Screen

Version/Model Number

10469593

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091361

Product Code

LIP

Product Code Name

ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Public Device Record Key

5b60ff60-9e43-4e94-802d-a967b1926f4e

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

-