Organization name

Cupid Limited

SRN

IN-MF-000033199

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW011

  Contraindicated to be used for any other purpose than qualitative detection of Hepatitis B Surface Antigen in serum or plasma samples.
• CW010

  Read the instructions for use before carrying out the test and Instructions must be followed exactly for get accurate results.

Primary placement in Austria; available across 32 countries total.

Trade name

CupiKIT

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.

08906005286024

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.

890600528cuphbsL5

Reference / catalog number

CUPHBS-01

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.

IVDR Class D

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Hepatitis B Surface Antigen (HBsAg) Test Kit is a single use device for preliminary qualitative detection of HBsAg, which gives results at 20 minutes. The kit includes a test cassette and a dropper packed in a individual primary aluminium foil pouch along with a desiccant. Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus.

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.

• W0105090201HBSAG - RT & POC

• IVDR Class D medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.