Catalog Number

PRD-04081

Brand Name

APTIMA

Version/Model Number

HBV VIRAL LOAD ASSAY TER

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

-

Product Code

MKT

Product Code Name

Hepatitis Viral B Dna Detection

Public Device Record Key

76406bb6-a6b8-47bb-bdac-d4b8a5493454

Public Version Date

April 21, 2021

Public Version Number

3

DI Record Publish Date

January 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-