Fujirebio Diagnostics AB

Address:Elof Lindalvs Gata 13,Gothenburg Vastra Gotaland,SE

Want to know more about this Organization? Request more information now!

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

Multi-Analyte Controls, All Kinds (Assayed) (JJY) (4) Cytokeratin Fragments 21-1 Eia Kit (OVK) (1) Test, Epithelial Ovarian Tumor Associated Antigen (He4) (OIU) (1)

Premarket Exempt

No Yes

Clear

Tumor Marker Control - 17350066140043 Catalog Number :

Device Class : 1

Duns Number: 357159631

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

CYFRA 21-1 EIA - 17350066140135 Catalog Number :

Device Class : 2

Duns Number: 357159631

Premarket Exempt : No

Product Code : OVK

Prescription Use : Yes

Device Count : 1

HE4 EIA - 17350066140326 Catalog Number :

Device Class : 2

Duns Number: 357159631

Premarket Exempt : No

Product Code : OIU

Prescription Use : Yes

Device Count : 1

Mesothelin Control - 17350066140524 Catalog Number :

Device Class : 1

Duns Number: 357159631

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Lung Marker Control - 17350066140531 Catalog Number :

Device Class : 1

Duns Number: 357159631

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

AMH Control - 17350066140579 Catalog Number :

Device Class : 1

Duns Number: 357159631

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Previous 1 Next