Catalog Number

2344800

Brand Name

Trinity Biotech

Version/Model Number

2344800

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K033064

Product Code

LJZ

Product Code Name

Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

Public Device Record Key

e015fe31-7327-40ff-aa72-ef2d34da1a57

Public Version Date

November 14, 2019

Public Version Number

1

DI Record Publish Date

November 06, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-