Catalog Number

AU-240

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218

Version/Model Number

AU-240

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 13, 2022

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

CKA

Product Code Name

NADH OXIDATION/NAD REDUCTION, ALT/SGPT

Public Device Record Key

1f581aff-23b5-4f5f-b8b8-0bde84f8f1d9

Public Version Date

October 17, 2022

Public Version Number

2

DI Record Publish Date

August 19, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-