Organization name

IBL International GmbH

SRN

DE-MF-000015709

Manufacturer status

Active

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

• Consult instructions for use
• Contains biological material of animal origin
• Contains biological material of human origin
• Exposure to radiation when using the device
• Biological risks
• Do not use if package is damaged
• Caution
• Caution, sharp edges

Primary placement in Germany; available across 32 countries total.

Trade name

Acetylcholine Receptor Autoantibodies (ARAb) RRA

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.

04049325033559

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.

4049325IVR06020001BQZ

Reference / catalog number

30221149

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 B

Applicable legislation

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

Status

On the market

Quantity

30

Additional product description

The Acetylcholine autoantibody radio receptor assay is intended for the semiquantitative determination of autoantibodies against the acetylcholine receptor in adult human serum and EDTA plasma. The measurement of highly specific autoantibodies against the acetylcholine receptor (AChr) is appropriate as an aid for diagnosis of myasthenia gravis (MG), a rare but long-term muscle disease leading to muscle weakness of varying severity. In diagnostics, the determination of autoantibodies against the acetylcholine receptor is used as the first screening tool in patients with suspected Myasthenia Gravis disease, as in around 80% of MG patients autoantibodies against AChR are detectable (seropositive MG). Furthermore determination of autoantibodies provides information concerning (patho-) physiological state of the patient. For definition of myasthenic subgroup, such as early-onset MG, late-onset MG, thymoma-associated or MuSK-associated MG, further diagnostic investigation is necessary. Subgroups will not be defined using this assay. Acetylcholine receptor from human muscle is used as antigen in this radio receptor assay. The receptors are labelled with 125I-alpha-bungarotoxin, which binds the receptors most specifically and almost irreversible. Autoantibodies present in the patient´s serum or plasma attach to the labelled receptors. The resulting immune complexes are precipitated with anti-human IgG. The amount of radioactivity of the sediment is directly proportional to the concentration of acetylcholine receptor autoantibodies of the sample. The assay requires general purpose laboratory instruments and consumables such as gamma counter, vortexer and pipettes to execute the test. The manual kit assay test instructions must be strictly adhered to and verified by the laboratory. Test results are calculated from a standard curve and compared to defined cut-off. The test kit is intended for professional laboratory.

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.

• W0102109022ACETYLCHOLIN RECEPTOR ANTIBODIES

• IVDR Class B medical devices in EUDAMED

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