Serum Control - Serum Control Level I, ß-Carotene in serum/plasma - Chromsystems Instruments + Chemicals GmbH

Duns Number:328712260

Device Description: Serum Control Level I, ß-Carotene in serum/plasma

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

0026

Brand Name

Serum Control

Version/Model Number

0026

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

JJX

Product Code Name

Single (Specified) Analyte Controls (Assayed And Unassayed)

Device Record Status

Public Device Record Key

1e7a70a4-9929-48bd-9353-b26781bd8fa1

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

July 30, 2020

Additional Identifiers

Package DI Number

04250317504463

Quantity per Package

5

Contains DI Package

04250317543455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CHROMSYSTEMS INSTRUMENTS + CHEMICALS GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 455
2 A medical device with a moderate to high risk that requires special controls. 92