Bartels® - Bartels® HSV Fluorescent Monoclonal Antibody Test - TRINITY BIOTECH PUBLIC LIMITED COMPANY

Duns Number:988298840

Device Description: Bartels® HSV Fluorescent Monoclonal Antibody Test

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More Product Details

Catalog Number

B1029-47

Brand Name

Bartels®

Version/Model Number

B1029-47

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

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

-

Product Code Details

Product Code

GQL

Product Code Name

Antisera, Fluorescent, Herpesvirus Hominis 1,2

Device Record Status

Public Device Record Key

a4e2b98c-5b2a-49c5-ac25-dcfee12e22a7

Public Version Date

May 10, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

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