Catalog Number

CAL1080

Brand Name

ClearChem Diagnostics Inc. Calcium

Version/Model Number

CAL1080

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CIC

Product Code Name

CRESOLPHTHALEIN COMPLEXONE, CALCIUM

Public Device Record Key

9777c92a-b80a-4160-acad-1ca86e16fde7

Public Version Date

May 31, 2018

Public Version Number

1

DI Record Publish Date

April 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-