FDA.reportPublic FDA data

Reagent

Primary DI
04250317511041
Brand
Reagent
Company
Chromsystems Instruments + Chemicals GmbH
Model
5001
Catalog number
5001
Device description
Mobile Phase, Catecholamines in plasma, Catecholamines in urine
Published
2020-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
04250317511041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317511041042503175110414250317511041

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
328712260
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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