Chromsystems Instruments + Chemicals GmbH

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

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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

Chromatographic/Fluorometric Method, Catecholamines (CHQ) (6) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (3) Calibrator, Multi-Analyte Mixture (JIX) (1)

Premarket Exempt

Yes

Clear

Dried Blood Control Bi-Level - 04250317502834 Catalog Number : 0191

Device Description : MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Co MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Bi-Level

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Dried Blood Control - 04250317502841 Catalog Number : 0192

Device Description : MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Co MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Dried Blood Control - 04250317502865 Catalog Number : 0193

Device Description : MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Co MassCheck® Amino Acids, Acylcarnitines inc. Succinylacetone, Dried Blood Spot Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Accessorie - 04250317502957 Catalog Number : 2010

Device Description : Tubes with screw caps for hydrolysis, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317502971 Catalog Number : 2020

Device Description : HPLC Reagent Kit, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317503008 Catalog Number : 2020/A1

Device Description : HPLC Reagent Kit, Preparation with Gilson Aspec®, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317503022 Catalog Number : 2020/A5

Device Description : HPLC Reagent Kit, Preparation with Gilson Aspec®, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317503046 Catalog Number : 2020/A9

Device Description : HPLC Reagent Kit, Preparation with Gilson Aspec®, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Reagent - 04250317503084 Catalog Number : 2021

Device Description : Mobile Phase, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

Calibration Standard - 04250317503114 Catalog Number : 2023

Device Description : Calibration Standard Metanephrines

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

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