Catalog Number

6101M-50

Brand Name

Immco Diagnostics, Inc.

Version/Model Number

6101M-50

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

K172254

Product Code

LSR

Product Code Name

Reagent, Borrelia Serological Reagent

Public Device Record Key

95594aeb-7dbc-4f85-b938-5bc0b5342ff5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-