Catalog Number

26200

Brand Name

MONOLISA™

Version/Model Number

26200

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

P060034

Product Code

LOM

Product Code Name

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Public Device Record Key

9644f1cb-ed0f-4223-abde-77d2c6c212ea

Public Version Date

July 29, 2021

Public Version Number

7

DI Record Publish Date

August 22, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-