Diagam

Address:Parc Eurasante,LOOS Hauts-de-France,FR

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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

Alpha-2-Macroglobulin, Antigen, Antiserum, Control (DEB) (2) Calibrator, Primary (JIS) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Yes

Clear

Alpha2-Macroglobulin - 05415168003476 Catalog Number : 08240396190

Device Description : Quantitative determination of Alpha2-Macroglobulin in human serum and heparinise Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on cobas c501/502 systems.

Device Class : 2

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : DEB

Prescription Use : Yes

Device Count : 1

Alpha2-Macroglobulin Serum CONT KIT - 05415168004763 Catalog Number : 08240426190

Device Description : Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems.

Device Class : 1

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : Yes

Device Count : 1

Alpha2-Macroglobulin CAL KIT - 05415168004770 Catalog Number : 08240400190

Device Description : Calibration of Alpha2-Macroglobulin assay on cobas c501/502 systems.

Device Class : 2

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : JIS

Prescription Use : Yes

Device Count : 1

Alpha2-macroglobulin - 05415168006873 Catalog Number : 09029524190

Device Description : In vitro diagnostic reagent for the quantitative determination of alpha2macroglo In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparinized plasma) by immunoturbidimetry on the cobas c systems.

Device Class : 2

Duns Number: 374384030

Premarket Exempt : Yes

Product Code : DEB

Prescription Use : Yes

Device Count : 1

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