Catalog Number

01-120002.B1

Brand Name

D3 Fastpoint

Version/Model Number

01-120002.B1

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

K093233

Product Code

LKT

Product Code Name

RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA

Public Device Record Key

9ca47713-31a9-435e-b54b-7297892a0834

Public Version Date

August 22, 2018

Public Version Number

1

DI Record Publish Date

July 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-