FDA.reportPublic FDA data

Reagent

Primary DI
04250317511560
Brand
Reagent
Company
Chromsystems Instruments + Chemicals GmbH
Model
51005
Catalog number
51005
Device description
Precipitation Reagent, 5-Hydroxyindoleacetic Acid 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
CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDAAcid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/SerotoninClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317511560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317511560042503175115604250317511560

GMDN Terms#

Term, Definition table
TermDefinition
HVA/VMA/5HIAA 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 qquantitative measurement of homovanillic acid (HVA), vanillylmandelic acid (VMA) and 5-hydroxyindoleacetic acid (5HIAA) 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
00840239013002Serotonin ELISADRG International IncCDA2023-08-23
004048474188665-HIAA ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDA2021-07-28
00404847413007Serotonin ELISADRG Instruments Gesellschaft mit beschränkter HaftungCDA2021-06-07
04250317505309Reagent KitChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317505347ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317505392ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317505415ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317507303Reagent Kit Chromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317507341ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317507389ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317507402ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317507426AccessorieChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317511485Reagent KitChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317511515ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317511546ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317511645ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27
04250317520098ReagentChromsystems Instruments + Chemicals GmbHCDA2020-08-27