Catalog Number

40-5065G/B-A

Brand Name

Trinity Biotech

Version/Model Number

40-5065G/B-A

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

K950829

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

b95d08bf-c8dc-4b38-99ab-18ae8cc73b5f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-