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

SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL (DHB) (5) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (2) Tryptase assay system (OYL) (2) ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) (NHX) (1)

Premarket Exempt

No Yes

Clear

Maintenance Solution Kit - 07333066000633 Catalog Number : 10-9476-01

Device Description : Contains ten ampoules of Maintenance Concentrate, one vial of Anti-Foam and one

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ImmunoCAP Tryptase - 07333066000893 Catalog Number : 10-9525-02

Device Description : Contains one bottle of Tryptase Conjugate and four vials of Tryptase Curve Contr

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : OYL

Prescription Use : Yes

Device Count : 1

ImmunoCAP Tryptase Calibrators - 07333066000909 Catalog Number : 10-9526-01

Device Description : Contains one vial of each Tryptase Calibrator (Cal-1, Cal-5, Cal-12.5, Cal-50, C

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : OYL

Prescription Use : Yes

Device Count : 1

Maintenance Solution Kit Large - 07333066000985 Catalog Number : 10-9537-01

Device Description : Contains eight ampules of Maintenance Concentrate for use with Phadia instruments.

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Phadia 100 - 07333066000992 Catalog Number : 12-3500-02

Device Description : Phadia 100

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

Phadia 1000 - 07333066001005 Catalog Number : 12-3800-01

Device Description : Phadia 1000

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

Phadia Information Data Manager Software Package - 07333066001012 Catalog Number : 12-3801-11

Device Description : Phadia Information Data Manager Software Package

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

Phadia 250 - 07333066001029 Catalog Number : 12-3900-01

Device Description : Phadia 250

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

Dilution Plate, Phadia 250 - 07333066001036 Catalog Number : 12-3907-08

Device Description : Dilution Plate, Phadia 250

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

Phadia 5000 - 07333066001043 Catalog Number : 12-4000-00

Device Description : Phadia 5000

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : DHB

Prescription Use : Yes

Device Count : 1

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