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

ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) (NHX) (5) Multi-analyte controls, all kinds (assayed) (JJY) (3) Autoantibodies, endomysial(tissue transglutaminase) (MVM) (1) Multi-analyte controls unassayed (OHQ) (1)

Premarket Exempt

No Yes

Clear

EliA CCP Positive Control 2500/5000 - 07333066020020 Catalog Number : 83-0008-81

Device Description : EliA CCP Positive Control 2500/5000

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

EliA M2 Positive Control 100 - 07333066020037 Catalog Number : 83-0014-81

Device Description : EliA M2 Positive Control 100

Device Class : 1

Duns Number: 354019424

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

EliA M2 Positive Control 250 - 07333066020044 Catalog Number : 83-0014-91

Device Description : EliA M2 Positive Control 250

Device Class : 1

Duns Number: 354019424

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

EliA IgG Calibrators - 07333066020051 Catalog Number : 83-1000-01

Device Description : Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal Contains one vial of each Calibrator (Cal-0, Cal-4, Cal-10, Cal-20, Cal-100, Cal-600) to form a complete calibration curve for EliA IgG method.

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

Quality Club EliA Autoimmunity - 07333066020068 Catalog Number : 83-1006-01

Device Description : Contains four different single-use vials with control samples, one vial for each Contains four different single-use vials with control samples, one vial for each month of a four months period.

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : OHQ

Prescription Use : Yes

Device Count : 1

EliA IgA Calibrators - 07333066020075 Catalog Number : 83-1013-01

Device Description : Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Ca Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : MVM

Prescription Use : Yes

Device Count : 1

EliA IgM Calibrators - 07333066020082 Catalog Number : 83-1049-01

Device Description : Contains one vial of each Calibrator (Cal-0, Cal-10, Cal-35, Cal-80, Cal-500, Ca Contains one vial of each Calibrator (Cal-0, Cal-10, Cal-35, Cal-80, Cal-500, Cal-1000) to form a complete calibration curve for EliA IgM method.

Device Class : 1

Duns Number: 354019424

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

Phadia 5000E - 07333066020907 Catalog Number : 12-4000-01

Device Description : Phadia 5000E

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

Phadia 5000E+E - 07333066020914 Catalog Number : 12-4000-02

Device Description : Phadia 5000E+E

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

Phadia 2500E - 07333066020921 Catalog Number : 12-4100-01

Device Description : Phadia 2500E

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

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