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

Urinalysis Controls (Assayed And Unassayed) (JJW) (6) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (4)

Premarket Exempt

Yes

Clear

Plasma Control - 04250317546487 Catalog Number : 0314

Device Description : MassCheck® Methylmalonic Acid Plasma Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Pasma Control - 04250317546494 Catalog Number : 0315

Device Description : MassCheck® Methylmalonic Acid Plasma Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Urine Control - 04250317546500 Catalog Number : 0317

Device Description : MassCheck® Methylmalonic Acid Urine Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Urine Control - 04250317546517 Catalog Number : 0318

Device Description : MassCheck® Methylmalonic Acid Urine Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

Urine Control - 04250317546524 Catalog Number : 0376

Device Description : MassCheck® total Metanephrines, Urine Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control - 04250317546531 Catalog Number : 0377

Device Description : MassCheck® total Metanephrines, Urine Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control - 04250317546562 Catalog Number : 0382

Device Description : MassCheck® VMA, HVA, 5-HIAA, Urine Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control - 04250317546579 Catalog Number : 0381

Device Description : MassCheck® VMA, HVA, 5-HIAA, Urine Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control - 04250317546586 Catalog Number : 0372

Device Description : MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level I

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control - 04250317546593 Catalog Number : 0373

Device Description : MassCheck® Catecholamines, free Metanephrines, Serotonine, Urine Control Level II

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

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