Catalog Number

7-H7541-CAL

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® HbA1c CAL SET PART# 7-H7541-CAL

Version/Model Number

7-H7541-CAL

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

LCP

Product Code Name

ASSAY, GLYCOSYLATED HEMOGLOBIN

Public Device Record Key

d6391fe4-5f40-4db5-add0-878c7dec870f

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

-