Catalog Number

CC638

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® IgM Immunoglobulin IgM CC638

Version/Model Number

CC638

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 27, 2018

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

CFF

Product Code Name

IMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)

Public Device Record Key

1db003e5-1227-4559-9961-8c6118dea626

Public Version Date

August 28, 2018

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

-