Reagent 3035

GUDID 04250317505415

Precipitation Reagent, Serotonin in serum/plasma/whole blood

Chromsystems Instruments + Chemicals GmbH

Multiple biogenic amine neurotransmitter IVD, reagent

• Primary Device ID: 04250317505415
• NIH Device Record Key: fa984a0a-4bfb-4729-bafb-441a5f4a1856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reagent
• Version Model Number: 3035
• Catalog Number: 3035
• Company DUNS: 328712260
• Company Name: Chromsystems Instruments + Chemicals GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de
• Phone: +4989189300
• Email: mailbox@chromsystems.de

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250317505415 [Primary]

FDA Product Code

• CDA: Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-04
• Device Publish Date: 2020-08-27

On-Brand Devices [Reagent]

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