Catalog Number

28200

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® SERUM CAL KIT Product No. 28200

Version/Model Number

28200

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

JIX

Product Code Name

CALIBRATOR, MULTI-ANALYTE MIXTURE

Public Device Record Key

bf391dae-af42-43f5-a20b-bf079d668f51

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-