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) (4) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (2) Reagent, coronavirus serological (QKO) (2) ANTI-SM ANTIBODY, ANTIGEN AND CONTROL (LKP) (1) ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) (NHX) (1)

Premarket Exempt

No Yes

Clear

Phadia 2500EE - 07333066020938 Catalog Number : 12-4100-02

Device Description : Phadia 2500EE

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : NHX

Prescription Use : Yes

Device Count : 1

EliA CoV Positive Control C1 250 - 07333066021232 Catalog Number : 83-0042-11

Device Description : EliA CoV Positive Control C1 250

Device Class :

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

EliA SARS-CoV-2-Sp1 IgG Well - 07333066021287 Catalog Number : DECC066630

Device Description : EliA SARS-CoV-2-Sp1 IgG Well

Device Class :

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : QKO

Prescription Use : Yes

Device Count : 1

EliA ANA 3 Positive Control 250 - 07333066021324 Catalog Number : 83-0041-11

Device Description : EliA ANA 3 Positive Control 250

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

EliA ANA 3 Positive Control 2500/5000 - 07333066021331 Catalog Number : 83-0041-21

Device Description : EliA ANA 3 Positive Control 2500/5000

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

EliA SmDP-S Well - 07333066021485 Catalog Number : DECC056720

Device Description : EliA SmDP-S Well

Device Class : 2

Duns Number: 354019424

Premarket Exempt : No

Product Code : LKP

Prescription Use : Yes

Device Count : 1

Phadia Maintenance Solution Small - 07333066022307 Catalog Number : 34-2317-93

Device Description : Phadia Maintenance Solution Small

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Phadia Maintenance Solution Large - 07333066022314 Catalog Number : 34-2317-94

Device Description : Phadia Maintenance Solution Large

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

EliA dsDNA Positive Control 250 - 07333066022420 Catalog Number : 83-0045-21

Device Description : EliA dsDNA Positive Control 250

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

EliA dsDNA Positive Control 2500/5000 - 07333066022437 Catalog Number : 83-0045-31

Device Description : EliA dsDNA Positive Control 2500/5000

Device Class : 1

Duns Number: 354019424

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : Yes

Device Count : 1

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