Catalog Number

V-BBSMUS

Brand Name

Borrelia B31 IgM ViraStripe® Test Kit

Version/Model Number

V-BBSMUS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K082329

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

71948bfa-ea45-44e6-95e0-718f6a6b3882

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-