Insti Hcv Antibody Test

by bioLytical Laboratories Inc. EUDAMED

Active European Union

Ref 90-1062-005 and 90-1062-006

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-00686597200704 Basic UDI-DI	Date13 Apr 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name: INSTI HCV Ab Test CE fr 50 and INSTI HCV Ab Test CE fr 300
Model / Reference: 90-1062-005 and 90-1062-006

Primary DI / UDI-DI: 00686597200704
Basic UDI-DI: B-00686597200704
EMDN Code: W0105020303 Hcv antibody (total)

Device Class: Class IVD Annex II List A
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CA-MF-000023304
Authorised representative: Emergo Europe B.V. NL-AR-000000116

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INSTI HIV Self Test (no pipette variant, packaged in a box))

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INSTI HIV Self Test (no pipette variant, packaged in a box)

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Insti Hcv Antibody Test

IVD Annex II List A

See all devices from Biolytical Laboratories Inc. →

Properties

Near-Patient Testing
Professional Testing

Other properties (8)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Reagent: No
Self Testing: No
Companion Diagnostics: No
Surgical Instrument: No