FDA.reportPublic FDA data

Plasma Calibration Standard

Primary DI
04250317514264
Brand
Plasma Calibration Standard
Company
Chromsystems Instruments + Chemicals GmbH
Model
67003
Catalog number
67003
Device description
Plasma Calibration Standard Malondialdehyde
Published
2019-05-17
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
JITCalibrator, Secondary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317514264PackageGS15In Commercial Distribution
04250317544155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317514264042503175142644250317514264
04250317544155042503175441554250317544155

GMDN Terms#

Term, Definition table
TermDefinition
Malondialdehyde IVD, kit, liquid chromatographyA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of malondialdehyde (MDA) in a clinical specimen, using a liquid chromatography method. MDA is a metabolite/biomarker of oxidative stress (e.g., lipid peroxidation) and high levels of MDA have been linked to patients with cystic fibrosis and other chronic respiratory diseases.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 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
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
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
07613336222331ISE Internal Standard Gen.2 conc.Roche Diagnostics GmbHJIT2026-03-20
04015630926091Testosterone II CalSet IIRoche Diagnostics GmbHJIT2026-02-23
04560189213418ST AIA-PACK PROG II CALIBRATOR SETTOSOH CORPORATIONJIT2026-02-02
00817089023222DiazymeDIAZYME LABORATORIES, INC.JIT2026-01-21
04562185403060HbA1c Calibrator Set (S)TOSOH CORPORATIONJIT2026-01-05
00380740189822AlinityAbbott GmbHJIT2026-01-01
00380740189846ARCHITECTAbbott GmbHJIT2026-01-01
00380740168742AlinityAbbott Ireland DiagnosticsJIT2025-12-11
07613336216958CalSet Phospho-Tau (181P) PlasmaRoche Diagnostics GmbHJIT2025-11-18
24560189216338CL AIA-PACK Prolactin II ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24560189216635CL AIA-PACK hs-E2 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185395451CL AIA-PACK T3 ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399671CL AIA-PACK Progesterone ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185399725CL AIA-PACK LH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
24562185400407CL AIA-PACK FSH ADJUSTER SETTOSOH CORPORATIONJIT2025-09-01
05711435000163ProNephro AKI™ (NGAL) Calibrator KitBioporto Diagnostics A/SJIT2025-08-28
00630414320304Atellica CH UAlb CALSiemens Healthcare Diagnostics Inc.JIT2025-08-11
07613336180822CalSet Cortisol III UrineRoche Diagnostics GmbHJIT2025-07-24
15099590763633Access Syphilis CalibratorsBeckman Coulter, Inc.JIT2025-05-07
04987595300011PATHFAST Sample Diluent 1PHC CORPORATIONJIT2025-04-18
04987595300028PATHFAST Sample Diluent 2PHC CORPORATIONJIT2025-04-18
04015630924288sFlT-1 CalSetRoche Diagnostics GmbHJIT2025-04-07
04015630925407CalSet PlGFRoche Diagnostics GmbHJIT2025-04-07
05055845400534Alere NT-proBNP for Alinity Calibrator KitAXIS-SHIELD DIAGNOSTICS LIMITEDJIT2025-02-27
08058056685285ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
08058056685315ACE CalibratorSENTINEL CH. SPAJIT2025-01-27
20758750034625VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
20758750035066VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-09-18
08430793243001HEMOSIL RIVAROXABAN CALIBRATORSINSTRUMENTATION LABORATORY COMPANYJIT2024-07-22
20758750034915VITROSORTHO CLINICAL DIAGNOSTICSJIT2024-04-25