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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (7) Drug Specific Control Materials (LAS) (2) Calibrator, Multi-Analyte Mixture (JIX) (1)

Premarket Exempt

Yes

Clear

Serum Control - 04250317546685 Catalog Number : 0338

Device Description : MassCheck® Steroid Panel 1&2, Serum Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Serum Control - 04250317546692 Catalog Number : 0339

Device Description : MassCheck® Steroid Panel 1&2, Serum Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Serum Control - 04250317546708 Catalog Number : 0340

Device Description : MassCheck® Steroid Panel 1&2, Serum Control Level III

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546715 Catalog Number : 0384

Device Description : MassCheck® Free Metanephrines, Plasma Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546722 Catalog Number : 0385

Device Description : MassCheck® Free Metanephrines, Plasma Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546739 Catalog Number : 0386

Device Description : MassCheck® Free Metanephrines, Plasma Control Level III

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546814 Catalog Number : 0250/XT

Device Description : MassCheck® Antiepileptic Drugs/EXTENDED, Plasma Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546821 Catalog Number : 0251/XT

Device Description : MassCheck® Antiepileptic Drugs/EXTENDED, Plasma Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Calibration Standard - 04250317546845 Catalog Number : 61003

Device Description : Plasma Calibration Standard Antibiotics

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Plasma Control - 04250317546852 Catalog Number : 0183

Device Description : Plasma Control Level I, Antibiotics 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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