Reagent - System Check Solution Set, MassChrom® VMA, HVA, - Chromsystems Instruments + Chemicals GmbH

Duns Number:328712260

Device Description: System Check Solution Set, MassChrom® VMA, HVA, 5-HIAA in urine

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More Product Details

Catalog Number

80810

Brand Name

Reagent

Version/Model Number

80810

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

CDF

Product Code Name

Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

Device Record Status

Public Device Record Key

4a6b73ef-0939-45b5-9dc6-b5cfb3bf41c3

Public Version Date

September 04, 2020

Public Version Number

1

DI Record Publish Date

August 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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