Catalog Number

AU-227

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® AMY RGT. KIT AU-227

Version/Model Number

AU-227

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

-

Product Code

JFJ

Product Code Name

CATALYTIC METHODS, AMYLASE

Public Device Record Key

2b1e433a-f2b2-418d-8a45-eda2119dfdf3

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-