FDA.reportPublic FDA data

Reagent

Primary DI
04250317537591
Brand
Reagent
Company
Chromsystems Instruments + Chemicals GmbH
Model
80610
Catalog number
80610
Device description
System Check Solution, MassChrom® Catecholamines, Metanephrines, Serotonin in urine
Published
2020-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CHQChromatographic/Fluorometric Method, Catecholamines

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CHQChromatographic/Fluorometric Method, CatecholaminesClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317537591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317537591042503175375914250317537591

GMDN Terms#

Term, Definition table
TermDefinition
Multiple biogenic amine neurotransmitter IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, norepinephrine, epinephrine), histamine, serotonin] and/or multiple biogenic amine neurotransmitter intermediate metabolites (e.g., metanephrine, normetanephrine, 3-methoxytyramine) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+4989189300mailbox@chromsystems.de

Regulatory Flags#

DUNS number
328712260
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250317501554Prefilter15009150092026-01-22
04250317501578Prefilter15011150112026-01-22
04250317536204Prefilter15061150612026-01-22
04250317537577Prefilter15071150712026-01-22
04250317554611Precolumn18010180102026-01-22
04250317555281Prefilter15013150132026-01-22
04250317558022Prefilter57016570162026-01-22
04250317558084Restrictor Capillary55018550182026-01-22
04250317555137Plasma Control0250-XT20250-XT22025-07-31
04250317555151Plasma Control0251-XT20251-XT22025-07-31
04250317510174Tube48010480102025-07-31
04250317552747Dried Blood Control019501952025-07-31
04250317552754Dried Blood Control019601962025-07-31
04250317552761Dried Blood Control019701972025-07-31
04250317554819Dried Blood Control029502952025-07-31
04250317554826Dried Blood Control029602962025-07-31
04250317554833Dried Blood Control029702972025-07-31
04250317554994Plasma Calibrator Set92025-XT292025-XT22025-07-31
04250317555120Plasma Control0250-XT20250-XT22025-07-31
04250317555144Plasma Control0251-XT20251-XT22025-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250317557070Reagent Chromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557087Reagent Chromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557506Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557513Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557544Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557551Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557568Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557575Reagent KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557582Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
04250317557599Basic KitChromsystems Instruments + Chemicals GmbHCHQ2025-06-20
00404847419085Adrenaline ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHQ2021-06-07
00404847427486Metanephrine (Urine) ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHQ2021-06-07
00404847431759Catcombi ELISADRG Instruments Gesellschaft mit beschränkter HaftungCHQ2021-06-07
04250317502957AccessorieChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503190ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503213ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503220ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503244ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503268AccessorieChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503275AccessorieChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503299ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317519276ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317526359ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317526366ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-31
04250317503084ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503138ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503145ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503169ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317503176ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28
04250317511058ReagentChromsystems Instruments + Chemicals GmbHCHQ2020-08-28