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

Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin (CDA) (4) Calibrator, Secondary (JIT) (2) Chromatography (Liquid, Gel), Clinical Use (KZR) (2) Calibrator, Multi-Analyte Mixture (JIX) (1) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (1)

Premarket Exempt

Yes

Clear

Whole Blood Calibrator Set - 04250317505125 Catalog Number : 28039

Device Description : 6PLUS1® Multilevel Whole Blood Calibrator Set MassTox® Immunosuppressants

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Calibration Standard - 04250317505217 Catalog Number : 3003

Device Description : Calibration Standard Serotonin

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317505309 Catalog Number : 3030

Device Description : HPLC Reagent Kit, Serotonin in serum/plasma/whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDA

Prescription Use : No

Device Count : 1

Reagent - 04250317505347 Catalog Number : 3031

Device Description : Mobile Phase, Serotonin in serum/plasma/whole blood/urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDA

Prescription Use : No

Device Count : 1

Calibration Standard - 04250317505378 Catalog Number : 3033

Device Description : Calibration Standard Serotonin

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIT

Prescription Use : No

Device Count : 1

Reagent - 04250317505392 Catalog Number : 3034

Device Description : Internal Standard, Serotonin in serum/plasma/whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDA

Prescription Use : No

Device Count : 1

Reagent - 04250317505415 Catalog Number : 3035

Device Description : Precipitation Reagent, Serotonin in serum/plasma/whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDA

Prescription Use : No

Device Count : 1

Plasma Control Bi-Level - 04250317505439 Catalog Number : 0031

Device Description : Plasma Control Bi-Level, Vitamin B6 in plasma/serum

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

HPLC Column - 04250317505675 Catalog Number : 31100

Device Description : HPLC Column Vitamin B6 in plasma/serum/whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

HPLC Column - 04250317505699 Catalog Number : 3130

Device Description : HPLC Column, Serotonin in serum/plasma /whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

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