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MAGLUMI Anti-ZnT8 (CLIA) Controls

Anti-ZnT8 (CLIA)

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145555382
Basic UDI-DI: 694714551085JE
Reference: 1602011085MT
EMDN: W0102152003
EMDN description: SPECIFIC PROTEIN CONTROLS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:42

Manufacturer products Authorised representative products Authorised representative actors View details

PCT Control

105-010703-00、105-010730-00、105-010219-00、105-010228-00、105-010248-00、105-010238-00、 105-010258-00

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06936415900762
Basic UDI-DI: 69449040004S-PCT*******M3
Reference: 105-010248-00
EMDN: W0102152008
EMDN description: CONTROLS FOR INDIVIDUAL AND SPECIFIC HORMONES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:37

Manufacturer products Authorised representative products Authorised representative actors View details

ACTIVE VITAMIN B12 CONTROL LEVEL 2 (Active Vitamin B12 CONTROL 2)

ACTIVE VITAMIN B12 CONTROL

IVD Class BIVDR 2017/746On the marketNo EU repHuman tissuesKitProfessional testingReagent

Manufacturer: Randox Laboratories Limited
Manufacturer SRN: XI-MF-000028410
UDI-DI: 05055273219036
Basic UDI-DI: 50552732BAVB12C173QK
Reference: VB10525
EMDN: W0102152006
EMDN description: ANAEMIA RELATED/VITAMIN CONTROLS
First on market country: Northern Ireland
Authorised representative: -
Last updated: 16.07.2026 09:46

Manufacturer products View details

μTASWako DCP Control L

995-60701, 999-61201, 995-61301, 991-61401

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164489
Basic UDI-DI: 49874814987481164413UA
Reference: 995-61301
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

μTASWako AFP-L3 Control L

999-60601, 997-60901, 997-61001, 993-61101

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

Manufacturer: FUJIFILM Wako Pure Chemical Corporation
Manufacturer SRN: JP-MF-000013944
UDI-DI: 14987481164441
Basic UDI-DI: 49874814987481164390UP
Reference: 997-61001
EMDN: W0102152005
EMDN description: TUMOUR MARKER CONTROLS
First on market country: Germany
Authorised representative: FUJIFILM Wako Chemicals Europe GmbH
Last updated: 16.07.2026 09:42

Manufacturer products Authorised representative products Authorised representative actors View details

PATHFAST B･R･A･H･M･S PCT Control

PATHFAST B·R·A·H·M·S PCT Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595302107
Basic UDI-DI: 4987595PF0221CWJ
Reference: 30210
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7022C · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

PATHFAST Presepsin Control

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesNear-patient testingProfessional testingReagent

Manufacturer: PHC Corporation
Manufacturer SRN: JP-MF-000008516
UDI-DI: 04987595302008
Basic UDI-DI: 4987595PF0201CW8
Reference: 30200
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Safety summary (SSCP/SSP): YM-R14-7020C · Rev. 6
Authorised representative: PHC Europe B.V.
Last updated: 16.07.2026 09:41

Manufacturer products Authorised representative products Authorised representative actors Open in EUDAMED View details

DNlite uPTM-FetA ELISA Kit – Standard

8105002

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879495010
Basic UDI-DI: 471987949E103057S
Reference: 8105002
EMDN: W0102152299
EMDN description: STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

DNlite uPTM-FetA ELISA Kit - Controls

8105001

IVD Class BIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Bio Preventive Medicine Corp.
Manufacturer SRN: TW-MF-000022845
UDI-DI: 04719879495003
Basic UDI-DI: 471987949E103047Q
Reference: 8105001
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Netherlands
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 09:32

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methotrexate Dilution Buffer

5026-0004-00

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testing

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00858724003209
Basic UDI-DI: 0858724003MTX026AJ7
Reference: 5026-0004-00
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details

00856743007062

Mycophenolic Acid Control

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

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007062
Basic UDI-DI: 0856743007MDI02406D
Reference: 240
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

00856743007055

Cyclosporine C2 Control

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

Manufacturer: More Diagnostics Inc
Manufacturer SRN: US-MF-000019469
UDI-DI: 00856743007055
Basic UDI-DI: 0856743007MDI020265
Reference: 202
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 06:41

Manufacturer products Authorised representative products Authorised representative actors View details

ARK Methotrexate II Dilution Buffer

5071-0004-00

IVD Class AIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testing

Manufacturer: ARK Diagnostics, Inc.
Manufacturer SRN: US-MF-000023925
UDI-DI: 00812101031223
Basic UDI-DI: 0858724003MTX071AJH
Reference: Reference Number
EMDN: W0102152201
EMDN description: TDM/DRUG STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:38

Manufacturer products Authorised representative products Authorised representative actors View details

Ethyl Glucuronide 200 Control Set

Ethyl Glucuronide Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008575
Basic UDI-DI: 0850624008CCEtG302HJ
Reference: 09976507190
EMDN: W0102152009
EMDN description: CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Buprenorphine 5 Qualitative Calibrator Set

Buprenorphine Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008070
Basic UDI-DI: 0850624008CCBUP02Y8
Reference: 08356661190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Fentanyl Qualitative Calibrator Set

Fentanyl Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008278
Basic UDI-DI: 0850624008CCFEN2024V
Reference: 09330097190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: AR Experts B.V.
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

6-Acetylmorphine Semi-Quantitative Calibrators Set

6-Acetylmorphine Calibrators and Controls

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testing

Manufacturer: Lin-Zhi International, Inc.
Manufacturer SRN: US-MF-000003373
UDI-DI: 00850624008056
Basic UDI-DI: 0850624008CC6AM02PL
Reference: 08240183190
EMDN: W0102152209
EMDN description: DRUGS OF ABUSE / TOXICOLOGY STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: CEpartner4U
Last updated: 16.07.2026 06:33

Manufacturer products Authorised representative products Authorised representative actors View details

Atellica IM VitDII Quality Control (VitDII QC)

IVDR_67_TTN_DUB-C_B_REAG_KIT_VitDII QC

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414649887
Basic UDI-DI: 0405686902371VP
Reference: 11698632
EMDN: W0102152099
EMDN description: CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

ADVIA Centaur NfL Quality Control (NfL QC)

IVDR_67_TTN_DUB-C_C_REAG_sNfL Control

IVD Class CIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016560
UDI-DI: 00630414635453
Basic UDI-DI: 0405686902257VQ
Reference: 11553994
EMDN: W0102152011
EMDN description: CONTROLS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:37

Manufacturer products Authorised representative products Authorised representative actors View details

N aTNFa Controls ADA

IVDR_27_MAR EB_B_N_aTNFa_Con_ADA_ETA_INF

IVD Class BIVDR 2017/746On the marketHuman tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414615400
Basic UDI-DI: 0405686902180VE
Reference: 10873740
EMDN: W0102152001
EMDN description: TDM/DRUG CONTROLS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:36

Manufacturer products View details