Catalog Number

20319

Brand Name

Sofia

Version/Model Number

20319

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

K173496

Product Code

LSR

Product Code Name

REAGENT, BORRELIA SEROLOGICAL REAGENT

Public Device Record Key

4f5d45e0-416d-4cd5-a873-6d5a90e463a2

Public Version Date

December 18, 2019

Public Version Number

1

DI Record Publish Date

December 10, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-