DiaSys Diagnostic Systems GmbH

Address:ALTE STRASSE 9,Holzheim Rhineland-Palatinate,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

Nitroprusside, Ketones (Urinary, Non-Quant.) (JIN) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Calibrator, Multi-Analyte Mixture (JIX) (1)

Premarket Exempt

Yes

Clear

β-Hydroxybutyrate 21 FS - 04051839002891 Catalog Number : 137119943018

Device Description : For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.

Device Class : 1

Duns Number: 328419718

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 1

β-Hydroxybutyrate 21 FS - 04051839002907 Catalog Number : 137119943019

Device Description : For the quantitative determination of beta-hydroxybutyrate in human serum or plasma.

Device Class : 1

Duns Number: 328419718

Premarket Exempt : Yes

Product Code : JIN

Prescription Use : Yes

Device Count : 1

β-Hydroxybutyrate 21 Tri-Level Controls - 04051839002914 Catalog Number : 595709943085

Device Description : For use as controls in quantitative procedures for β-Hydroxybutyrate

Device Class : 1

Duns Number: 328419718

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

β-Hydroxybutyrate 21 Bi-Level Controls - 04051839002921 Catalog Number : 595409943084

Device Description : For use as controls in quantative procedures for β-Hydroxybutyrate

Device Class : 1

Duns Number: 328419718

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

β-Hydroxybutyrate 21 Linearity Standards - 04051839002938 Catalog Number : 137209943052

Device Description : For use as linearity standards in quantitative procedures for β-Hydroxybutyrate

Device Class : 2

Duns Number: 328419718

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : Yes

Device Count : 1

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