Plasma Control 0095

GUDID 04250317515667

Plasma Control Level I, Malondialdeyhde in plasma/serum

Chromsystems Instruments + Chemicals GmbH

Malondialdehyde IVD, control
Primary Device ID04250317515667
NIH Device Record Key6482ebbe-c004-4af6-8c01-63c2adee3da4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlasma Control
Version Model Number0095
Catalog Number0095
Company DUNS328712260
Company NameChromsystems Instruments + Chemicals GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de
Phone+4989189300
Emailmailbox@chromsystems.de

Device Dimensions

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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -18 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250317515667 [Package]
Contains: 04250317544063
Package: [5 Units]
In Commercial Distribution
GS104250317544063 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-07
Device Publish Date2020-07-30

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04250317514394Plasma Control Level II, Amiodarone, Desethylamiodarone in serum/plasma
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04250317512260Plasma Control Level II, Tricyclic Antidepressants in serum/plasma
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04250317541390MassCheck® Antidepressants 2 /Psychostimulants /EXTENDED Plasma Control Level II
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04250317526311MassCheck® Anti-HIV Drugs, Plasma Control Level II
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