Catalog Number

LKIE1

Brand Name

IMMULITE®/IMMULITE® 1000 Systems TIE Total IgE

Version/Model Number

10380867

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

K960067

Product Code

JHR

Product Code Name

RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D, E)

Public Device Record Key

3437c45c-94ba-47ce-8591-ef79a32b0e77

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-