Catalog Number

02N43-004

Brand Name

RealTime

Version/Model Number

02N43-004

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

P080026,P080026

Product Code

MKT

Product Code Name

Hepatitis Viral B DNA Detection

Public Device Record Key

0dd1dacf-25be-401b-b134-acd729209eac

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

July 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-