FDA.report

Plasma Calibration Standard

Primary DI
04250317514486
Brand
Plasma Calibration Standard
Company
Chromsystems Instruments + Chemicals GmbH
Model
68003
Catalog number
68003
Device description
Plasma Calibration Standard Coenzyme Q10
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

Related Records

Contact Domains

Product Codes

CodeName
JITCalibrator, Secondary

Product Code Classifications

CodeDeviceSpecialtyClass
JITCalibrator, SecondaryClinical Chemistry2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250317514486PackageGS15In Commercial Distribution
04250317544025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250317514486042503175144864250317514486
04250317544025042503175440254250317544025

GMDN Terms

TermDefinition
Coenzyme Q10 (CoQ10) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative detection of coenzyme Q10 (CoQ10), also known as ubiquinone, in a clinical specimen.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius-18 Degrees Celsius

Sterilization Methods

Method

Contacts

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

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04250317536204Prefilter15061150612026-01-22
04250317537577Prefilter15071150712026-01-22
04250317554611Precolumn18010180102026-01-22
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04250317554819Dried Blood Control029502952025-07-31
04250317554826Dried Blood Control029602962025-07-31
04250317554833Dried Blood Control029702972025-07-31
04250317554994Plasma Calibrator Set92025-XT292025-XT22025-07-31
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04250317557070Reagent 203320332025-06-20

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