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983 device results listed.

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Estrone-3-glucuronide (E3G) Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrE3G102FNY
Basic UDI-DI: B-acrE3G102FNY
Reference: acrE3G102F
EMDN: W0102160399
EMDN description: FERTILITY/PREGNANCY RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

CEA Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrCEA402FTE
Basic UDI-DI: B-acrCEA402FTE
Reference: acrCEA402F
EMDN: W0102030112
EMDN description: CARCINOEMBRYONIC ANTIGEN
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

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Calprotectin Test Kit (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrCAL601GVY
Basic UDI-DI: B-acrCAL601GVY
Reference: acrCAL601G
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Spain
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

Manufacturer products Authorised representative products Authorised representative actors View details

CA72-4 Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrCA724402F58
Basic UDI-DI: B-acrCA724402F58
Reference: acrCA724402F
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

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Hemoglobin (Hb) Control Solution

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrBCHB-LSQ
Basic UDI-DI: B-acrBCHB-LSQ
Reference: acrBCHB-L
EMDN: W0101050299
EMDN description: SPECIFIC CONTROLS (CC) - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

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AFP Test Cassette

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-acrAFP402FXW
Basic UDI-DI: B-acrAFP402FXW
Reference: acrAFP402F
EMDN: W0102039001
EMDN description: ALPHAFETOPROTEIN
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:14

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HPV 16/18 Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-THPV-ACOT50293
Basic UDI-DI: B-THPV-ACOT50293
Reference: THPV-ACOT502
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

HPV Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-THPV-ACO502B2U
Basic UDI-DI: B-THPV-ACO502B2U
Reference: THPV-ACO502B
EMDN: W0105099099
EMDN description: VIROLOGY - RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

H.pylori/FOB/Transferrin Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-THFT-ACO637HF
Basic UDI-DI: B-THFT-ACO637HF
Reference: THFT-ACO637
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

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PGⅠ/PG Ⅱ/H. pylori antibody/Gastrin 17 Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TGT-ACOR445QUJ
Basic UDI-DI: B-TGT-ACOR445QUJ
Reference: TGT-ACOR445Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

PGⅠ/PG Ⅱ/H. pylori antibody Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TGT-ACOR435QUD
Basic UDI-DI: B-TGT-ACOR435QUD
Reference: TGT-ACOR435Q
EMDN: W0102160199
EMDN description: SPECIFIC PROTEINS RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

FOB/Transferrin/Calprotectin/Lactoferrin Combo Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TFTCL-ACO645XE
Basic UDI-DI: B-TFTCL-ACO645XE
Reference: TFTCL-ACO645
EMDN: W0101060399
EMDN description: FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Bladder Tumor Antigen Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-TBT-ACO1029G
Basic UDI-DI: B-TBT-ACO1029G
Reference: TBT-ACO102
EMDN: W0102160299
EMDN description: TUMOUR MARKER RT & POC - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

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Vitamin D Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OVDA-ACO402BN
Basic UDI-DI: B-OVDA-ACO402BN
Reference: OVDA-ACO402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OVB-ACO40294
Basic UDI-DI: B-OVB-ACO40294
Reference: OVB-ACO402
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Vitamin B12 Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OVB-ACO3028X
Basic UDI-DI: B-OVB-ACO3028X
Reference: OVB-ACO302
EMDN: W0101060199
EMDN description: BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Sickle Cell Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OSCD-ACO4029Z
Basic UDI-DI: B-OSCD-ACO4029Z
Reference: OSCD-ACO402
EMDN: W0103010202
EMDN description: HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-ORF-ACO4028L
Basic UDI-DI: B-ORF-ACO4028L
Reference: ORF-ACO402
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Pyridinium Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OPYD-ACO102NM
Basic UDI-DI: B-OPYD-ACO102NM
Reference: OPYD-ACO102
EMDN: W0101060299
EMDN description: URINE TESTING - OTHER
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details

Parathyroid Hormone (PTH) Rapid Test

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: Acro Biotech Inc.
Manufacturer SRN: US-MF-000017832
UDI-DI: D-OPT-ACO402FG
Basic UDI-DI: B-OPT-ACO402FG
Reference: OPT-ACO402
EMDN: W0102060202
EMDN description: ANGIOTENSIN I / II
First on market country: Germany
Authorised representative: VidaQuick Biotech S.L.
Last updated: 12.08.2026 23:13

Manufacturer products Authorised representative products Authorised representative actors View details