Catalog Number

C1-5

Brand Name

Alfa Wassermann

Version/Model Number

C1-5

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K930104

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Public Device Record Key

c7c85054-9e9e-481a-9da6-1594087e9af2

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

July 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-