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

Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) (JMA) (4) Chromatography (Liquid, Gel), Clinical Use (KZR) (2) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Calibrator, Multi-Analyte Mixture (JIX) (1) Drug Specific Control Materials (LAS) (1)

Premarket Exempt

Yes

Clear

Plasma Control - 04250317546869 Catalog Number : 0184

Device Description : Plasma Control Level II, Antibiotics in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Plasma Calibrator Set - 04250317547088 Catalog Number : 92026/XT2

Device Description : 3PLUS1® Multilevel Plasma Calibrator Set MassTox® Neuroleptics 2/ EXTENDED2

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Precolumn Cartridge - 04250317547262 Catalog Number : 18061

Device Description : Precolum Cartridge 4/10, Antibiotics in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Analytical Column - 04250317547293 Catalog Number : 62130

Device Description : Analytical Column, MassChrom® 25-OH-Vitamin D3/D2 3-epi-25-OH-Vitamin D3

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317547460 Catalog Number : 65765/F

Device Description : HPLC Reagent Kit for automated sample preparation, Vitamin C in plasma/serum

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JMA

Prescription Use : No

Device Count : 1

Accessorie - 04250317547477 Catalog Number : 65757

Device Description : 96 Well Filter Plates for automated sample preparation, Vitamin C in plasma/serum

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JMA

Prescription Use : No

Device Count : 1

Accessorie - 04250317547484 Catalog Number : 65758

Device Description : Collection Plates for automated sample preparation, Vitamin C in plasma/serum

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JMA

Prescription Use : No

Device Count : 1

Accessorie - 04250317547491 Catalog Number : 65759

Device Description : Pierceable Adhesive Seals for 96 Well Plates for automated sample preparation, Pierceable Adhesive Seals for 96 Well Plates for automated sample preparation, Vitamin C in plasma/serum

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JMA

Prescription Use : No

Device Count : 1

Plasma Control Bi-Level - 04250317547538 Catalog Number : 0227/XT2

Device Description : MassCheck® Neuroleptics 2 /EXTENDED2 Plasma Control Bi-Level

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Control - 04250317547668 Catalog Number : 0010

Device Description : Endocrine plasma control, normal range

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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