ImmunoFA Toxoplasma IgM Positive Control - Positive control for use with ImmunoFA Toxoplasma - Genbio

Duns Number:940425333

Device Description: Positive control for use with ImmunoFA Toxoplasma IgM kit.

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More Product Details

Catalog Number

1341

Brand Name

ImmunoFA Toxoplasma IgM Positive Control

Version/Model Number

800-1341

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K803134

Product Code Details

Product Code

GLZ

Product Code Name

Antigens, If, Toxoplasma Gondii

Device Record Status

Public Device Record Key

859bd0dc-f8b1-423b-a615-693644c7f568

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENBIO" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32