Catalog Number

LSKTI1(D)

Brand Name

IMMULITE®/IMMULITE® 1000 Systems RTI Turbo Troponin I

Version/Model Number

10642238

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

K991795

Product Code

MMI

Product Code Name

IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Public Device Record Key

fb184980-85b1-4012-b8ef-fdf3b379ba7e

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

-