Chromsystems Instruments + Chemicals GmbH

Address:Am Haag 12,Gr�felfing Bavaria,DE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Drug Specific Control Materials (LAS) (4) Alcohol Control Materials (DKC) (2) Chromatographic/Fluorometric Method, Catecholamines (CHQ) (2) Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin (CDF) (1) Calibrator, Secondary (JIT) (1)

Premarket Exempt

Yes

Clear

Urine Control - 04250317546067 Catalog Number : 0368

Device Description : MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : DKC

Prescription Use : No

Device Count : 1

Urine Control - 04250317546111 Catalog Number : 0369

Device Description : MassCheck® Ethyl Glucuronide, Ethyl Sulfate, Urine Control Level III

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : DKC

Prescription Use : No

Device Count : 1

Reagent - 04250317546234 Catalog Number : 80804/5

Device Description : Internal Standard Mix, MassChrom® VMA, HVA, 5-HIAA in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Urine Calibration Standard - 04250317546333 Catalog Number : 4009

Device Description : Urine Calibration Standard Serotonin

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546388 Catalog Number : 0214/XT

Device Description : MassCheck® Antidepressants 1/EXTENDED Plasma Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546395 Catalog Number : 0215/XT

Device Description : MassCheck® Antidepressants 1/EXTENDED Plasma Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546401 Catalog Number : 0211/XT

Device Description : MassCheck® Neuroleptics 1/EXTENDED Plasma Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546418 Catalog Number : 0212/XT

Device Description : MassCheck® Neuroleptics 1/EXTENDED Plasma Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Reagent - 04250317546449 Catalog Number : 80604/5

Device Description : Internal Standard Mix, MassChrom® Catecholamines, free Metanephrines, Serotonin in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Reagent - 04250317546463 Catalog Number : 81004

Device Description : Internal Standard Mix, MassChrom® Free Metanephrines in plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

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