Catalog Number

KT022279

Brand Name

ePlex

Version/Model Number

BCID_FP Cartridge Pouch

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

K182690

Product Code

PAM

Product Code Name

Gram-Positive Bacteria And Their Resistance Markers

Public Device Record Key

be261bcc-e804-4f21-96b9-bca7a727d93d

Public Version Date

August 30, 2019

Public Version Number

1

DI Record Publish Date

August 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-