Catalog Number

-

Brand Name

ACCURUN 51 Multi-Marker Hepatitis S2000 (US) 1 1 x 5.0 mL

Version/Model Number

2000-0065

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

-

Product Code

DGQ

Product Code Name

Whole Blood Plasma, Antigen, Antiserum, Control

Public Device Record Key

d57ec337-31c4-44c9-971d-a19699f97522

Public Version Date

March 28, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-