Plasma Control - MassCheck® Tricylclic Antidepressants TCA 2, - Chromsystems Instruments + Chemicals GmbH

Duns Number:328712260

Device Description: MassCheck® Tricylclic Antidepressants TCA 2, Plasma Control Level II

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More Product Details

Catalog Number

0248

Brand Name

Plasma Control

Version/Model Number

0248

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

LAS

Product Code Name

Drug Specific Control Materials

Device Record Status

Public Device Record Key

c3af5e82-222f-4bb6-9d33-dccee43b86ab

Public Version Date

August 14, 2020

Public Version Number

1

DI Record Publish Date

August 06, 2020

Additional Identifiers

Package DI Number

04250317524331

Quantity per Package

5

Contains DI Package

04250317545336

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