Organization name

Asuragen, Inc.

SRN

US-MF-000011830

Manufacturer status

Active

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

• CW010

  Consult instructions for use
• CW007

  Do not use if package is damaged

Primary placement in France; available across 32 countries total.

Trade name

AmplideX SMA Plus Kit (50 rxn)

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.

00863840000278

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-00863840000278

Reference / catalog number

A00055

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 — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The AmplideX® SMA Plus Kit is an in vitro nucleic acid amplification kit intended to aid in the screening of carriers of and diagnosis of spinal muscular atrophy (SMA). The kit generates copy numbers of exon 7 of both SMN1 and SMN2 reported as 0, 1, 2, 3, or ≥ 4 genomic copies. The kit is designed for PCR with extracted genomic DNA from human whole blood performed on standard laboratory-validated thermal cyclers, followed by resolution on a general laboratory-validated genetic analyzer or capillary electrophoresis (CE) platform. Additionally, the kit assesses chimeric genes with both SMN1 and SMN2 sequences, variants SMN1 c.*3+80T>G and SMN1 c.*211_*212del associated with gene duplication, and variant SMN2 c.859G>C associated with disease severity.

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.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER

• IVDD — General medical devices in EUDAMED

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