FDA.reportPublic FDA data

Plasma Calibration Standard

Primary DI
04250317510853
Brand
Plasma Calibration Standard
Company
Chromsystems Instruments + Chemicals GmbH
Model
49035
Catalog number
49035
Device description
Plasma Calibration Standard Alprazolam, Trazodone
Published
2019-03-22
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250317510853PackageGS15In Commercial Distribution
04250317544124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250317510853042503175108534250317510853
04250317544124042503175441244250317544124

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-therapy therapeutic drug monitoring IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple drugs used for different types of therapies (e.g., antibiotic, anticonvulsant, and cardiovascular) 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 Temperature2 Degrees Celsius8 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
10673486014013Teco Diagnostics Chemistry CalibratorTECO DIAGNOSTICSJIX2026-03-20
03701700817802ELICAL 2 VITALSCIENTIFICJIX2026-03-04
05430003908648SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908655SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908662SEEKER®Lacar MDX TechnologiesJIX2026-01-15
05430003908679SEEKER®Lacar MDX TechnologiesJIX2026-01-15
04250317554994Plasma Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2025-07-31
07613336232156Ionify CalSet Steroids and Vitamin DRoche Diagnostics GmbHJIX2025-06-25
00850053916267IDG/SanzayIDG/SANZAY CorporationJIX2024-07-03
08430793040761Aptiva® APS IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
08430793040907Aptiva® APS IgM CalibratorsINOVA DIAGNOSTICS, INC.JIX2024-03-11
00630414304915Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
04580262010314Calibrator 2TOKYO BOEKI MEDISYS INC.JIX2023-12-18
08430793040181Aptiva® CTD Essential CalibratorsINOVA DIAGNOSTICS, INC.JIX2023-12-14
00816776020544MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020568MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020582MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
00816776020599MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2023-12-05
10852676007060Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
00811403011087CO2 Alkaline BufferDiamond Diagnostics Inc.JIX2023-06-05
00816776020247MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-12-22
00817302024494CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 1 DT908CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024500CAROLINA LIQUID CHEMISTRIES CORP.® ISE CALIBRATOR 2 DT909CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00817302024517CAROLINA LIQUID CHEMISTRIES CORP.® ISE SELECTIVITY CHECK DT910CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2022-08-19
00380740164973ARCHITECTABBOTT IRELANDJIX2022-07-12
00380740164980AlinityABBOTT IRELANDJIX2022-07-12
04250317551115Urine Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-07-08
04250317552365Saliva Calibrator SetChromsystems Instruments + Chemicals GmbHJIX2022-06-21
00816776020513MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05
00816776020537MassTrakWATERS TECHNOLOGIES CORPORATIONJIX2022-04-05