Catalog Number

01-123304

Brand Name

D3 Fastpoint

Version/Model Number

01-123304

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GNS

Product Code Name

ANTISERA, HAI, INFLUENZA VIRUS A, B, C

Public Device Record Key

4595ce88-e9ce-4606-a778-c6e92856e9ba

Public Version Date

March 15, 2019

Public Version Number

1

DI Record Publish Date

March 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-