Catalog Number

25175

Brand Name

Bio-Rad Laboratories, Inc.

Version/Model Number

25175

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

K960092

Product Code

LGD

Product Code Name

ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII

Public Device Record Key

635c8a86-bb81-4eb8-8612-9dd6a44d0073

Public Version Date

July 29, 2021

Public Version Number

5

DI Record Publish Date

September 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-