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67 device results listed.

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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

K-ASSAY Haptoglobin

Haptoglobin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020153
Basic UDI-DI: B-00816426020153
Reference: KAI-022
EMDN: W0102010302
EMDN description: HAPTOGLOBIN
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

Microalbumin Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020139
Basic UDI-DI: B-00816426020139
Reference: KAI-019
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 IgM

IgM Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020115
Basic UDI-DI: B-00816426020115
Reference: KAI-015
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
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 IgG

IgG Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020108
Basic UDI-DI: B-00816426020108
Reference: KAI-014
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
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 IgA

IgA Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020092
Basic UDI-DI: B-00816426020092
Reference: KAI-013
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Complement C4

Complement C4 Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020085
Basic UDI-DI: B-00816426020085
Reference: KAI-010
EMDN: W0102010205
EMDN description: COMPLEMENT COMPONENT C4
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Complement C3

Complement C3 Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020078
Basic UDI-DI: B-00816426020078
Reference: KAI-009
EMDN: W0102010203
EMDN description: COMPLEMENT COMPONENT C3/C3C
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Apo E

Apo E Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020061
Basic UDI-DI: B-00816426020061
Reference: KAI-007
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Apo CIII

Apo CIII Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426020054
Basic UDI-DI: B-00816426020054
Reference: KAI-006
EMDN: W0102010499
EMDN description: LIPOPROTEINS - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:36

Manufacturer products Authorised representative products Authorised representative actors View details