Catalog Number

08240400190

Brand Name

Alpha2-Macroglobulin CAL KIT

Version/Model Number

08240400190

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JIS

Product Code Name

Calibrator, Primary

Public Device Record Key

39ebe769-7185-4bb5-b3f1-dff2acff84c4

Public Version Date

January 16, 2020

Public Version Number

1

DI Record Publish Date

January 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-