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

Acid, Trifluoroacetic, Vitamin A, Hexane Extraction (JOA) (7) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (2) Chromatography (Liquid, Gel), Clinical Use (KZR) (1)

Premarket Exempt

Yes

Clear

Serum Control Bi-Level - 04250317505736 Catalog Number : 0032

Device Description : Serum Control Bi-Level, Vitamins A and E in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317505743 Catalog Number : 32000

Device Description : HPLC Reagent Kit, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

Reagent - 04250317505774 Catalog Number : 32001

Device Description : Mobile Phase, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

Reagent - 04250317505828 Catalog Number : 32004

Device Description : Internal Standard, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

Reagent - 04250317505842 Catalog Number : 32005

Device Description : Precipitation Reagent, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

Reagent - 04250317505866 Catalog Number : 32006

Device Description : Extraction Buffer, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

HPLC Column - 04250317505880 Catalog Number : 32100

Device Description : HPLC Column, ß-Carotene in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : KZR

Prescription Use : No

Device Count : 1

Whole Blood Control Bi-Level - 04250317505903 Catalog Number : 0033

Device Description : Whole Blood Control Bi-Level, Vitamins B1/B2 in whole blood

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Reagent Kit - 04250317505958 Catalog Number : 34000

Device Description : HPLC Reagent Kit, Vitamins A and E in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

Reagent - 04250317505996 Catalog Number : 34001

Device Description : Mobile Phase, Vitamins A and E in serum/plasma

Device Class : 1

Duns Number: 328712260

Premarket Exempt : Yes

Product Code : JOA

Prescription Use : No

Device Count : 1

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