Trinity Biotech - 40-2027L B. burgdorferi WB Weakly Reactive IgG - MARDX DIAGNOSTICS, INC.

Duns Number:154281349

Device Description: 40-2027L B. burgdorferi WB Weakly Reactive IgG Control, 120µL

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More Product Details

Catalog Number

40-2027L

Brand Name

Trinity Biotech

Version/Model Number

40-2027L

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

K950829

Product Code Details

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Device Record Status

Public Device Record Key

5d903cc1-bc82-444e-9b71-afe1519ca614

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 19, 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