Catalog Number

LKRM1(D)

Brand Name

IMMULITE®/IMMULITE® 1000 Systems Rubella IgM

Version/Model Number

10374044

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

K012077

Product Code

LFX

Product Code Name

ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Public Device Record Key

1a7f0d29-ae5b-4f07-b31f-b4b63dd90bc3

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

-