Catalog Number

08924163160

Brand Name

Elecsys HIV combi PT

Version/Model Number

08924163160

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

BP160050

Product Code

MZF

Product Code Name

Test, HIV detection

Public Device Record Key

ba67ad4f-239f-4d78-a45b-363f1a37240c

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-