Diamedix - "720-300 Toxoplasma IgG Test Kit" - DIAMEDIX CORPORATION

Duns Number:151765328

Device Description: "720-300 Toxoplasma IgG Test Kit"

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More Product Details

Catalog Number

-

Brand Name

Diamedix

Version/Model Number

720-300

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K981498

Product Code Details

Product Code

LGD

Product Code Name

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

Device Record Status

Public Device Record Key

2208e109-0ff7-4410-ac45-acccf4eef43e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAMEDIX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 33