Euro-Diagnostica AB

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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

Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (4) Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) (NHX) (1) Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (DBL) (1) Radioimmunoassay, Gastrin (CGC) (1) Radioimmunoassay, Glucagon (JME) (1)

Premarket Exempt

No Yes

Clear

WIESLAB ANCA Screen kit - 07340058410639 Catalog Number : CP111

Device Class : 2

Duns Number: 559894501

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

WIESLAB antiGBM, ANCA Screen kit - 07340058410707 Catalog Number : GCP100

Device Class : 2

Duns Number: 559894501

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

WIESLAB anti-GBM semi quantitative kit - 07340058410721 Catalog Number : GP104X

Device Class : 2

Duns Number: 559894501

Premarket Exempt : No

Product Code : DBL

Prescription Use : No

Device Count : 1

IMMUNOSCAN CCPlus - 07340058410868 Catalog Number : RA-96PLUS

Device Class : 2

Duns Number: 559894501

Premarket Exempt : No

Product Code : NHX

Prescription Use : No

Device Count : 1

WIESLAB Capture PR3 ANCA - 07340058410936 Catalog Number : CapPR3 US

Device Class : 2

Duns Number: 559894501

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

WIESLAB Capture MPO-ANCA - 07340058410943 Catalog Number : CapMPO US

Device Class : 2

Duns Number: 559894501

Premarket Exempt : No

Product Code : MOB

Prescription Use : No

Device Count : 1

EURIA Gastrin - 07340058412015 Catalog Number : MD302

Device Class : 1

Duns Number: 559894501

Premarket Exempt : Yes

Product Code : CGC

Prescription Use : No

Device Count : 1

EURIA Glucagon - 07340058412077 Catalog Number : RB310

Device Class : 1

Duns Number: 559894501

Premarket Exempt : Yes

Product Code : JME

Prescription Use : No

Device Count : 1

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