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802 device results listed.

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EliA IgM Calibrator Well

EliA IgM Method reagents

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014708
Basic UDI-DI: 7333066BUDI0089MQ
Reference: 14-5527-01
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Celikey IgG Well

EliA Celikey IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014678
Basic UDI-DI: 7333066BUDI0086MJ
Reference: 14-5518-01
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Celikey IgA Well

EliA Celikey IgA

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014661
Basic UDI-DI: 7333066BUDI0085MG
Reference: 14-5517-01
EMDN: W0102100601
EMDN description: TISSUE TRANSGLUTAMINASE ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA IgA Calibrator Well

EliA IgA Method Reagents

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014654
Basic UDI-DI: 7333066BUDI0082MA
Reference: 14-5516-01
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA CCP Well

EliA CCP

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014647
Basic UDI-DI: 7333066BUDI0080M6
Reference: 14-5515-01
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA GBM Well

EliA GBM

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014630
Basic UDI-DI: 7333066BUDI0025LW
Reference: 14-5514-01
EMDN: W0102109014
EMDN description: ANTIBODIES TO GLOMERULAR BASAL MEMBRANE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA RNP70 Well

EliA RNP70

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014623
Basic UDI-DI: 7333066BUDI0079MM
Reference: 14-5511-01
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Dummy Well

System Accessories

IVD Class AIVDR 2017/746On the marketAnimal tissuesProfessional testing

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014616
Basic UDI-DI: 7333066BUDI0026LY
Reference: 14-5510-01
EMDN: W01029003
EMDN description: BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IC)
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA IgG Calibrator Well

EliA IgG Method Reagents

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014609
Basic UDI-DI: 7333066BUDI0077MH
Reference: 14-5509-01
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Jo-1 Well

EliA Jo-1

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014586
Basic UDI-DI: 7333066BUDI0076MF
Reference: 14-5507-01
EMDN: W0102100108
EMDN description: JO-1
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA CENP Well

EliA CENP

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014562
Basic UDI-DI: 7333066BUDI0075MD
Reference: 14-5505-01
EMDN: W0102100115
EMDN description: ANTI-CENTROMERE ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA La Well

EliA La

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014555
Basic UDI-DI: 7333066BUDI0074MB
Reference: 14-5504-01
EMDN: W0102100113
EMDN description: SS-B
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Ro Well

EliA Ro

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014548
Basic UDI-DI: 7333066BUDI0073M9
Reference: 14-5503-01
EMDN: W0102100112
EMDN description: SS-A
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA U1RNP Well

EliA U1RNP

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066014524
Basic UDI-DI: 7333066BUDI0072M7
Reference: 14-5501-01
EMDN: W0102100114
EMDN description: U1-SNRNP - ANTIBODIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:16

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EliA Calprotectin 2 Conjugate 50

EliA Calprotectin 2

IVD Class BIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013572
Basic UDI-DI: 7333066BUDI0044M2
Reference: 83-1127-01
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

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EliA M2 Positive Control 2500/5000

EliA M2

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013527
Basic UDI-DI: 7333066BUDI0122LV
Reference: 83-1105-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA Calprotectin Negative Control 250

EliA Calprotectin 2

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013367
Basic UDI-DI: 7333066BUDI0116M2
Reference: 83-1085-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA APS Positive Control 2500/5000

EliA Control

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013183
Basic UDI-DI: 7333066BUDI0020LL
Reference: 83-1078-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA CCP Positive Control 250

EliA CCP

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066013015
Basic UDI-DI: 7333066BUDI0081M8
Reference: 83-1035-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details

EliA ANA Positive Control 250

EliA Control

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagentSingle use

Manufacturer: Phadia AB
Manufacturer SRN: SE-MF-000014170
UDI-DI: 07333066012995
Basic UDI-DI: 7333066BUDI0047M8
Reference: 83-1033-01
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:15

Manufacturer products View details