Catalog Number

BL-204B

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® Lipoprotein (a) Assay Kit

Version/Model Number

BL-204B

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

K180074

Product Code

DFC

Product Code Name

LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

e5a4bf4f-930e-436b-a7b4-038a13758f98

Public Version Date

June 05, 2020

Public Version Number

2

DI Record Publish Date

September 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-