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

Chromatography (Liquid, Gel), Clinical Use (KZR) (6) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Chromatographic/Fluorometric Method, Catecholamines (CHQ) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Yes

Clear

Reagent - 04250317503299 Catalog Number : 2099

Device Description : Interference Mix, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CHQ

Prescription Use : No

Device Count : 1

HPLC Column - 04250317503336 Catalog Number : 2120

Device Description : HPLC Column, Metanephrines in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Whole Blood Control Bi-Level - 04250317503350 Catalog Number : 0022

Device Description : Whole Blood Control Bi-Level (I+II), Vitamin B6 in whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

HPLC Column - 04250317503633 Catalog Number : 22100/F

Device Description : HPLC Column Fast Elution, Antiepileptic Drugs in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

HPLC Column - 04250317503657 Catalog Number : 22100/HR

Device Description : HPLC Column High Resolution, Antiepileptic Drugs in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

HPLC Column - 04250317504203 Catalog Number : 24100

Device Description : HPLC Column, Levetiracetam (Keppra®) in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Serum Control Bi-Level - 04250317504234 Catalog Number : 0025

Device Description : Serum Control Bi-Level, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

HPLC Column - 04250317504425 Catalog Number : 25100

Device Description : HPLC Column, Amiodarone, Desethylamiodarone in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

HPLC Column - 04250317504692 Catalog Number : 26100

Device Description : HPLC Column, Olanzapine, Desmethylolanzapine in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Serum Control Bi-Level - 04250317504890 Catalog Number : 0028

Device Description : Serum Control Bi-Level, 25-OH-Vitamin D3/D2 in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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