Catalog Number

85375

Brand Name

E. coli reference strain K20

Version/Model Number

85375

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GMZ

Product Code Name

ANTIGENS, ALL TYPES, ESCHERICHIA COLI

Public Device Record Key

a2947162-25db-463a-8cfe-a1beaaea5abe

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

August 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-