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73 device results listed.

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K-ASSAY Lp(a) Calibrator

Lp(a) Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020573
Basic UDI-DI: B-00816426020573
Reference: KAI-018C
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Multi-Analyte Calibrator

Multi-Analyte Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020566
Basic UDI-DI: B-00816426020566
Reference: KAI-016C
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY CRP Calibrator

CRP Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020559
Basic UDI-DI: B-00816426020559
Reference: KAI-012C
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY hsCRP

hsCRP Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020498
Basic UDI-DI: B-00816426020498
Reference: KAI-160
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Factor XIII

Factor XIII Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020467
Basic UDI-DI: B-00816426020467
Reference: KAI-105
EMDN: W0103020213
EMDN description: COAGULATION FACTOR XIII
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Ferritin

Ferritin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020450
Basic UDI-DI: B-00816426020450
Reference: KAI-095
EMDN: W0102070102
EMDN description: FERRITIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Microalbumin Calibrator

Microalbumin Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020443
Basic UDI-DI: B-00816426020443
Reference: KAI-020C
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Apo E Calibrator

Apo E Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020436
Basic UDI-DI: B-00816426020436
Reference: KAI-025C
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Insulin Calibrator

Insulin Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020412
Basic UDI-DI: B-00816426020412
Reference: KAI-072C
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Prealbumin Calibrator

Prealbumin Calibrator

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020405
Basic UDI-DI: B-00816426020405
Reference: KAI-054C
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY CRP (3)

CRP (3) Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020344
Basic UDI-DI: B-00816426020344
Reference: KAI-082
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY ASO

ASO Reagent

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020337
Basic UDI-DI: B-00816426020337
Reference: KAI-078
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Cystatin C

Cystatin C Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020320
Basic UDI-DI: B-00816426020320
Reference: KAI-074
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Insulin

Insulin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020306
Basic UDI-DI: B-00816426020306
Reference: KAI-071
EMDN: W0102060103
EMDN description: INSULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Microalbumin (L)

Microalbumin Reagent (L)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020290
Basic UDI-DI: B-00816426020290
Reference: KAI-057
EMDN: W0102010309
EMDN description: ALBUMIN (IC) INCL. UALBUMIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Alpha-1 Microglobulin

Alpha-1 Microglobulin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020283
Basic UDI-DI: B-00816426020283
Reference: KAI-056
EMDN: W0102019004
EMDN description: A1-MICROGLOBULIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Prealbumin

Prealbumin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020276
Basic UDI-DI: B-00816426020276
Reference: KAI-053
EMDN: W0102010305
EMDN description: PRE-ALBUMIN / TRANSTHYRETIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Lp(a)

Lp(a) Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020245
Basic UDI-DI: B-00816426020245
Reference: KAI-044
EMDN: W0102010405
EMDN description: LIPOPROTEIN ( A )
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY CRP

CRP Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020184
Basic UDI-DI: B-00816426020184
Reference: KAI-026
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Transferrin

Transferrin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020160
Basic UDI-DI: B-00816426020160
Reference: KAI-023
EMDN: W0102010307
EMDN description: TRANSFERRIN
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:38

Manufacturer products Authorised representative products Authorised representative actors View details