FDA.reportPublic FDA data

Master Column

Primary DI
04250317522900
Brand
Master Column
Company
Chromsystems Instruments + Chemicals GmbH
Model
92110
Catalog number
92110
Device description
MassTox® TDM MasterColumn® Series A
Published
2020-08-20
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
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
04250317522900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317522900042503175229004250317522900

GMDN Terms#

Term, Definition table
TermDefinition
High performance liquid chromatography analyser column IVDA component of a high performance liquid chromatograph (HPLC) analyser that functions as a narrow flow-through tube through which different chemical constituents of a sample pass in a high pressure liquid stream at different rates, depending on their various chemical and physical properties and their interaction with a specific column filling. The internal diameter of the HPLC tubing (typically ranges from under 0.3 mm to greater than 10 mm) determines the quantity of analyte that can be loaded and analyser sensitivity. The tubes are made of various materials including stainless steel and fused silica.

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
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
true
Expiration date on label
false
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
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
04250317555168Plasma Control Bi-Level0249-XT20249-XT22025-07-31
04250317557070Reagent 203320332025-06-20

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
04250317519948Precolumn 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