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 - 04250317545619 Catalog Number : 0342

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

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Serum Control - 04250317545626 Catalog Number : 0343

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

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Serum Control - 04250317545633 Catalog Number : 0345

Device Description : MassCheck® Steroid Panel 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 - 04250317545640 Catalog Number : 0346

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

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Plasma Control - 04250317545657 Catalog Number : 0228/XT2

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

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Plasma Control - 04250317545664 Catalog Number : 0229/XT2

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

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

Whole Blood Calibration Standard - 04250317545671 Catalog Number : 52003

Device Description : Whole Blood Calibration Standard Vitamins B1/B6

Device Class : 2

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Whole Blood Control - 04250317545695 Catalog Number : 0165

Device Description : Whole Blood Control Level I, Vitamins B1/B6 in whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Whole Blood Control - 04250317545701 Catalog Number : 0167

Device Description : Whole Blood Control Level II, Vitamins B1/B6 in whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Serum Control - 04250317545718 Catalog Number : 0256

Device Description : MassCheck® 25-OH-Vitamin D3/D2 Serum Control Level III

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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