Trinity Biotech - B. pertussis WB Positive IgG Control, 250 µL - MARDX DIAGNOSTICS, INC.

Duns Number:154281349

Device Description: B. pertussis WB Positive IgG Control, 250 µL

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More Product Details

Catalog Number

40-6025

Brand Name

Trinity Biotech

Version/Model Number

40-6025

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

-

Product Code Details

Product Code

GOX

Product Code Name

Antigen, B. Pertussis

Device Record Status

Public Device Record Key

ff307d56-9cc6-4693-84a7-bbf6caa5836c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MARDX DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 76