Trinity Biotech - Oxalate Standards 0.50 MMOL/L - TRINITY BIOTECH PUBLIC LIMITED COMPANY

Duns Number:988298840

Device Description: Oxalate Standards 0.50 MMOL/L

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More Product Details

Catalog Number

591-3

Brand Name

Trinity Biotech

Version/Model Number

591-3

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

K883525

Product Code Details

Product Code

LPW

Product Code Name

System, Test, Oxalate

Device Record Status

Public Device Record Key

ce51c122-bf68-4627-9047-a1c85d571c54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRINITY BIOTECH PUBLIC LIMITED COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 32