Catalog Number

LKTXP1

Brand Name

IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgG

Version/Model Number

10381268

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

K962936

Product Code

LGD

Product Code Name

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Public Device Record Key

8ab16ab1-469b-4718-b2cd-6689f5ac82ed

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

-