Catalog Number

AU-632

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® APOA RGT. KIT AU-632

Version/Model Number

AU-632

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

Yes

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

-

FDA Premarket Submission

-

Product Code

DER

Product Code Name

ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

15c239d8-5dd9-40ee-8df2-e631fa097c5a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-