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, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin (CDF) (9) Drug Specific Control Materials (LAS) (1)

Premarket Exempt

Yes

Clear

Accessorie - 04250317500397 Catalog Number : 1008

Device Description : Sample Clean Up Columns, VMA, HVA, 5-HIAA in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Accessorie - 04250317500403 Catalog Number : 1008/A

Device Description : Sample Clean Up Columns, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500465 Catalog Number : 1011

Device Description : Mobile Phase, VMA, HVA, 5-HIAA in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500496 Catalog Number : 1013

Device Description : Finisher, VMA, HVA, 5-HIAA in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500519 Catalog Number : 1044/B/A1

Device Description : Internal Standard, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500526 Catalog Number : 1044/B/A5

Device Description : Internal Standard, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500533 Catalog Number : 1044/B/A9

Device Description : Internal Standard, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500557 Catalog Number : 1077

Device Description : Elution Buffer, VMA, HVA, 5-HIAA in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Reagent - 04250317500564 Catalog Number : 1077/A5

Device Description : Elution Buffer, VMA, HVA, 5-HIAA in urine, Preparation with the Gilson® ASPEC

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : CDF

Prescription Use : No

Device Count : 1

Plasma Control Bi-Level - 04250317500953 Catalog Number : 0131

Device Description : Plasma Control Bi-Level Perazine, Quetiapine, Citalopram

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

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