Organization name

bioLytical Laboratories Inc.

SRN

CA-MF-000023304

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

Primary placement in Netherlands; available across 31 countries total.

Trade name

INSTI HCV Test Controls

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00686597200766

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-00686597200766

Reference / catalog number

90-1067

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDD — Annex II List A

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The INSTI HCV Test Controls are intended to be used only with the INSTI HCV Antibody Test (INSTI).The INSTI HCV Test Controls have been designed for use with the INSTI HCV Antibody Test to validate the correct performance of the test procedure in the hands of the operator.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105094001CONTROLS INFECTIOUS IMMUNOLOGY - RT & POC

• IVDD — Annex II List A medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.