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

Chromatography (Liquid, Gel), Clinical Use (KZR) (5) Urinalysis Controls (Assayed And Unassayed) (JJW) (4) Drug Specific Control Materials (LAS) (1)

Premarket Exempt

Yes

Clear

Urine Control Bi-Level - 04250317501127 Catalog Number : 0138

Device Description : Urine Control Bi-Level, o-Cresol, p-Cresol, Phenol in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control Bi-Level - 04250317501226 Catalog Number : 0141

Device Description : Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic A Urine Control Bi-Level, Hippuric / Methylhippuric/ Mandelic / Phenylglyoxylic Acids in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Urine Control Bi-Level - 04250317501271 Catalog Number : 0144

Device Description : Urine Control Bi-Level, Porphyrins in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Plasma Control Bi-Level - 04250317501325 Catalog Number : 0147

Device Description : Plasma Control Bi-Level, Olanzapine, Desmethylolanzapine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : LAS

Prescription Use : No

Device Count : 1

HPLC Column - 04250317501813 Catalog Number : 15390

Device Description : HPLC Column, Hemoglobin Variants

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

HPLC Column - 04250317502018 Catalog Number : 15490

Device Description : HPLC Column, ß-Thalassemia Screening

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Urine Control Bi-Level - 04250317502148 Catalog Number : 0161

Device Description : Urine Control Bi-Level, t,t-Muconic acid in urine

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJW

Prescription Use : No

Device Count : 1

Precolumn Cartridge - 04250317502452 Catalog Number : 17037

Device Description : Precolum Cartridge 4/10, Vitamin B2 in whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Precolumn Cartridge - 04250317502506 Catalog Number : 17046

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

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Precolumn Cartridge - 04250317502537 Catalog Number : 17049

Device Description : Precolum Cartridge 4/10, Benzodiazepines, Tricyclic Antidepressants in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

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