Phadia AB

Address:RAPSGATAN 7P,UPPSALA,SE

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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

Multi-analyte controls, all kinds (assayed) (JJY) (3) System, test, radioallergosorbent (rast) immunological (DHB) (3) Antibodies, gliadin (MST) (2) IGE, ANTIGEN, ANTISERUM, CONTROL (DGC) (1) Tryptase assay system (OYL) (1)

Premarket Exempt

No Yes

Clear

ImmunoCAP Specific IgG Conjugate - 07333066019826 Catalog Number : 34-2294-41

Device Description : ImmunoCAP Specific IgG Conjugate

Device Class : 1

Duns Number: 354019424

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

ImmunoCAP Tryptase Control - 07333066019833 Catalog Number : 34-2297-41

Device Description : ImmunoCAP Tryptase Control

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : OYL

Prescription Use : Yes

Device Count : 1

ImmunoCAP Autoimmunity Specific IgG Sample Diluent - 07333066019840 Catalog Number : 34-2316-11

Device Description : ImmunoCAP Autoimmunity Specific IgG Sample Diluent

Device Class : 1

Duns Number: 354019424

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

ImmunoCAP Autoimmunity Specific IgG Sample Diluent - 07333066019857 Catalog Number : 34-2325-31

Device Description : ImmunoCAP Autoimmunity Specific IgG Sample Diluent

Device Class : 1

Duns Number: 354019424

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

ImmunoCAP Total IgE Conjugate 400 - 07333066019864 Catalog Number : 34-2325-42

Device Description : ImmunoCAP Total IgE Conjugate 400

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DGC

Prescription Use : Yes

Device Count : 1

Stop Solution - 07333066019871 Catalog Number : 34-2325-51

Device Description : Stop Solution

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Specific IgE Negative Control - 07333066019888 Catalog Number : 34-2326-31

Device Description : ImmunoCAP Specific IgE Negative Control

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

Development Solution - 07333066019895 Catalog Number : 34-2329-01

Device Description : Development Solution

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

ImmunoCAP Gliadin IgA/IgG Control Low - 07333066019901 Catalog Number : 34-2332-41

Device Description : ImmunoCAP Gliadin IgA/IgG Control Low

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : MST

Prescription Use : Yes

Device Count : 1

ImmunoCAP Gliadin IgA Control High - 07333066019918 Catalog Number : 34-2332-51

Device Description : ImmunoCAP Gliadin IgA Control High

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : MST

Prescription Use : Yes

Device Count : 1

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