FDA.reportPublic FDA data

Analytes Mix

Primary DI
04250317557605
Brand
Analytes Mix
Company
Chromsystems Instruments + Chemicals GmbH
Model
1033
Catalog number
1033
Device description
Analytes Mix, VMA, HVA, 5-HIAA in urine
Published
2025-06-20
Public version status
New
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
CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDFAcid, Vanilmandelic, Diazo, P-Nitroaniline/VanillinClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317557605PackageGS15In Commercial Distribution
04250317557612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317557605042503175576054250317557605
04250317557612042503175576124250317557612

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
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+498918930100mailbox@chromsystems.com

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
04250317537591Reagent80610806102020-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250317557612Analytes MixChromsystems Instruments + Chemicals GmbHCDF2025-06-20
04250317557476Basic KitChromsystems Instruments + Chemicals GmbHCDF2025-06-20
04250317557483Reagent KitChromsystems Instruments + Chemicals GmbHCDF2025-06-20
04250317500281ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500328ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500335ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500403AccessorieChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500519ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500526ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500533ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317500564ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317517555ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-31
04250317543240ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317546234ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500069Reagent KitChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500106Reagent KitChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500120Reagent KitChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500144Reagent KitChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500250ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500274ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500311ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500397AccessorieChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500465ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500496ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317500557ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317536662Reagent Kit Chromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317537294ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317537300ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317537393ReagentChromsystems Instruments + Chemicals GmbHCDF2020-08-27
04250317537423Reagent KitChromsystems Instruments + Chemicals GmbHCDF2020-08-27