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Omlipo C3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930714
Basic UDI-DI: B-06971225930714
Reference: OP33050
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo UsCRP Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930707
Basic UDI-DI: B-06971225930707
Reference: OP25100
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo RF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930691
Basic UDI-DI: B-06971225930691
Reference: OP23100
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo RF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930684
Basic UDI-DI: B-06971225930684
Reference: OP23050
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo ASO Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930660
Basic UDI-DI: B-06971225930660
Reference: OP21050
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo AT3 Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930653
Basic UDI-DI: B-06971225930653
Reference: OP19050
EMDN: W0103020602
EMDN description: ANTITHROMBIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo CER Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930646
Basic UDI-DI: B-06971225930646
Reference: OP18050
EMDN: W0102010301
EMDN description: CERULOPLASMIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo HPT Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930639
Basic UDI-DI: B-06971225930639
Reference: OP16050
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo TRF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930622
Basic UDI-DI: B-06971225930622
Reference: OP15050
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo AAG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930615
Basic UDI-DI: B-06971225930615
Reference: OP13050
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo PAB Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930608
Basic UDI-DI: B-06971225930608
Reference: OP12050
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo ALB Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930592
Basic UDI-DI: B-06971225930592
Reference: OP11050
EMDN: W01010201
EMDN description: ALBUMIN (CC)
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo IgM Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930585
Basic UDI-DI: B-06971225930585
Reference: OP09050
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo IgG Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930578
Basic UDI-DI: B-06971225930578
Reference: OP04050
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

CRP Control M

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930554
Basic UDI-DI: B-06971225930554
Reference: CPZK105
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

HbA1c Control High Level

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930547
Basic UDI-DI: B-06971225930547
Reference: HBDM072H
EMDN: W0101050205
EMDN description: DIABETES CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo IgA Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930561
Basic UDI-DI: B-06971225930561
Reference: OP01050
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

Urine TRF Control

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930530
Basic UDI-DI: B-06971225930530
Reference: DM068
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Control Level 3

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930516
Basic UDI-DI: B-06971225930516
Reference: DM026H
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Control Level 1

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930509
Basic UDI-DI: B-06971225930509
Reference: DM026L
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details