Reagent 80675

GUDID 04250317537317

Neutralisation Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine

Chromsystems Instruments + Chemicals GmbH

Multiple biogenic amine neurotransmitter IVD, reagent
Primary Device ID04250317537317
NIH Device Record Keycc86e9d7-445c-41b3-b76a-294e581877b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameReagent
Version Model Number80675
Catalog Number80675
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

Device Dimensions

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

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104250317537317 [Primary]

FDA Product Code

CHQChromatographic/Fluorometric Method, Catecholamines

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-04
Device Publish Date2020-08-27

On-Brand Devices [Reagent]

04250317550705Pre-mixed Solution
04250317536778Internal Standard Mix, MassChrom® Free Metanephrines in plasma
04250317537478Internal Standard Mix, MassChrom® Catecholamines, free Metanephrines, Serotonin in urine
04250317537447Internal Standard Mix, MassChrom® VMA, HVA, 5-HIAA in urine
04250317500588Potential Optimisation Mix, VMA, HVA, 5-HIAA in urine
04250317540058Mobile Phase B, MassChrom® Free Metanephrines in plasma
04250317540041Mobile Phase A, MassChrom® Free Metanephrines in plasma
04250317539953Tuning Mix, MassChrom® Free Metanephrines in plasma
04250317539946System Check Solution, MassChrom® Free Metanephrines in plasma
04250317539922Rinsing Solution, MassChrom® Free Metanephrines in plasma
04250317539915Elution Buffer, MassChrom® Free Metanephrines in plasma
04250317539908Dilution Buffer, MassChrom® Free Metanephrines in plasma
04250317539892Wash Buffer 2, MassChrom® Free Metanephrines in plasma
04250317538864Hydrolysis Buffer, MassChrom® Total Metanephrines (free + conjugated) in urine
04250317538857Internal Standard mix, MassChrom® Total Metanephrines (free + conjugated) in urine
04250317537843System Check Solution Set, MassChrom® VMA, HVA, 5-HIAA in urine
04250317537812Tuning Mix, MassChrom® VMA, HVA, 5-HIAA in urine
04250317537614Adjustment Reagent, MassChrom® Catecholamines, free Metanephrines, Serotonin in urine
04250317537591System Check Solution, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537584Tuning Mix, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537454Internal Standard Mix, MassChrom® Catecholamines, free Metanephrines, Serotonin in urine
04250317537393Internal Standard Mix, MassChrom® VMA, HVA, 5-HIAA in urine
04250317537355Dilution Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537348Elution Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537331Wash Buffer 2, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537324Wash Buffer 1, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537317Neutralisation Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537300Stabilisation Buffer, MassChrom® VMA, HVA, 5-HIAA in urine
04250317537294Stabilisation Buffer, MassChrom® VMA, HVA, 5-HIAA in urine
04250317537287Dilution Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537270Elution Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537263Wash Buffer 2, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537256Wash Buffer 1, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317537249Neutralisation Buffer, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
04250317536785Wash Buffer 1, MassChrom® Free Metanephrines in plasma
04250317536631Rinsing Solution, MassChrom® Biogenic Amines/Metabolites in urine, Chromatographic Platform
04250317536624Mobile Phase B, MassChrom® Biogenic Amines/Metabolites in urine, Chromatographic Platform
04250317536617Mobile Phase A, MassChrom® Biogenic Amines/Metabolites in urine, Chromatographic Platform
04250317535801Internal Standard, Vitamin C in plasma/serum
04250317526823Internal Standard, Vitamins A and E in serum/plasma, automated with 96 Well Filter Plates
04250317526779Pre-mixed Reaction Tubes, Vitamins A and E in serum/plasma
04250317520098Neutralisation Buffer, Serotonin in urine
04250317513854Mobile Phase, Vitamin C in plasma/serum
04250317511645Internal Standard 5-Hydroxyindoleacetic acid in urine
04250317511560Precipitation Reagent, 5-Hydroxyindoleacetic Acid in urine
04250317511546Internal Standard, 5-Hydroxyindoleacetic Acid in urine
04250317511515Mobile Phase, 5-Hydroxyindoleacetic Acid in urine
04250317511379Extraction Buffer, Catecholamines in plasma
04250317511232Wash Buffer, Catecholamines in plasma
04250317511195Internal Standard, Catecholamines in plasma

Trademark Results [Reagent]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REAGENT
REAGENT
97187886 not registered Live/Pending
ROQLogic, Inc.
2021-12-23
REAGENT
REAGENT
97175173 not registered Live/Pending
ROQLogic, Inc.
2021-12-16
REAGENT
REAGENT
85374890 4332441 Dead/Cancelled
inVentiv Health, Inc.
2011-07-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.