FDA.reportPublic FDA data

Precolumn Cartridge

Primary DI
04250317519948
Brand
Precolumn Cartridge
Company
Chromsystems Instruments + Chemicals GmbH
Model
18044
Catalog number
18044
Device description
Precolum Cartridge 4/10, Porphyrins 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
KZRChromatography (Liquid, Gel), Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZRChromatography (Liquid, Gel), Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317519948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317519948042503175199484250317519948

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
Manufacturing date on label
true

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
04250317558084Restrictor CapillaryChromsystems Instruments + Chemicals GmbHKZR2026-01-22
04250317553454HPLC ColumnChromsystems Instruments + Chemicals GmbHKZR2024-02-08
04250317553461Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2024-02-08
04250317502452Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317502506Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317502537Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519757Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519795Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519818Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519825Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519856Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519863Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519870Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519887Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519917Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519924Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519931Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519979Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317519986Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317520005Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317520012Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317520043Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317520050Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317520067Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317520074Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317532039Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317538628Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317547262Precolumn CartridgeChromsystems Instruments + Chemicals GmbHKZR2020-08-27
04250317501813HPLC ColumnChromsystems Instruments + Chemicals GmbHKZR2020-08-20
04250317502018HPLC ColumnChromsystems Instruments + Chemicals GmbHKZR2020-08-20