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200 device results listed.

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HemosIL Special Test Control Level 1

0020011000

IVD Class BIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950453062
Basic UDI-DI: 84269504530627G
Reference: 0020011000
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:04

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Homocysteine Controls

0020007900

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950453031
Basic UDI-DI: 842695045303175
Reference: 0020007900
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 03.07.2026 13:04

Manufacturer products Authorised representative products Authorised representative actors View details

APCr Controls

APC Resistance Controls

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Pentapharm AG
Manufacturer SRN: CH-MF-000020620
UDI-DI: 07640175460105
Basic UDI-DI: 76401754608045232190QK
Reference: 08045232190
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.07.2026 06:39

Manufacturer products Authorised representative products Authorised representative actors View details

MRX Specialty Abnormal Control

Specialty Abnormal Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320288
Basic UDI-DI: 7350060320206Q
Reference: K5022
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

MRX Specialty Normal Control

Specialty Normal Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320271
Basic UDI-DI: 73500603201977
Reference: K5021
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

MRX Routine Abnormal Control

Routine Abnormal Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320264
Basic UDI-DI: 73500603201875
Reference: K5040
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

MRX Routine Normal Control

Routine Normal Control

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Nordic Biomarker AB
Manufacturer SRN: SE-MF-000022201
UDI-DI: 27350060320257
Basic UDI-DI: 73500603201773
Reference: K5039
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 05:02

Manufacturer products View details

D-Dimer Control High

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153003240
Basic UDI-DI: 6438153BU00066BX
Reference: 981869
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

D-Dimer Control

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer SRN: FI-MF-000001479
UDI-DI: 16438153003233
Basic UDI-DI: 6438153BU00064BT
Reference: 981868
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Finland
Authorised representative: -
Last updated: 02.07.2026 09:05

Manufacturer products View details

QC2

2021EU

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: APIRO Diagnostics Kft.
Manufacturer SRN: HU-MF-000043501
UDI-DI: 25999862992235
Basic UDI-DI: 59998629922021EU_1U3
Reference: 2021EU
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Hungary
Authorised representative: -
Last updated: 02.07.2026 07:46

Manufacturer products View details

QC1

2011EU

IVD Class CIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: APIRO Diagnostics Kft.
Manufacturer SRN: HU-MF-000043501
UDI-DI: 25999862992013
Basic UDI-DI: 59998629922011EU_1TN
Reference: 2011EU
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Hungary
Authorised representative: -
Last updated: 02.07.2026 07:46

Manufacturer products View details

sthemO FVII QC

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 13607450015154
Basic UDI-DI: 3607450CTLS0021QZ
Reference: 01515
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 13:00

Manufacturer products View details

STA® - Quali-Clot I

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Diagnostica Stago
Manufacturer SRN: FR-MF-000017089
UDI-DI: 13607450009825
Basic UDI-DI: 3607450CTLG0005LX
Reference: 00982
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: France
Authorised representative: -
Last updated: 01.07.2026 12:59

Manufacturer products View details

HemosIL Apixaban Controls

0020014300

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950866879
Basic UDI-DI: 8426950866879BV
Reference: 0020014300
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Rivaroxaban Controls

0020013700

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950632849
Basic UDI-DI: 84269506328498V
Reference: 0020013700
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Dabigatran Controls

0020013500

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950632825
Basic UDI-DI: 84269506328258F
Reference: 0020013500
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL D-Dimer HS 500 Controls

0020013100

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950584933
Basic UDI-DI: 8426950584933AB
Reference: 0020013100
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL D-Dimer Controls

0020013000

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950581925
Basic UDI-DI: 84269505819259P
Reference: 0020013000
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:25

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL AcuStar D-Dimer Controls

0009802100

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesKitProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950498032
Basic UDI-DI: 84269504980329N
Reference: 0009802100
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details

HemosIL Plasma Coagulation Control Level II

0020010800

IVD Class CIVDR 2017/746On the marketDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Instrumentation Laboratory Company
Manufacturer SRN: US-MF-000035586
UDI-DI: 08426950498025
Basic UDI-DI: 84269504980259R
Reference: 0020010800
EMDN: W0103020702
EMDN description: CONTROL PLASMA FOR HAEMOSTASIS
First on market country: Italy
Authorised representative: Instrumentation Laboratory SpA
Last updated: 30.06.2026 15:24

Manufacturer products Authorised representative products Authorised representative actors View details