SPOT-it TREC, KREC & SMN1 Screening Kit

Organization name

ImmunoIVD AB

SRN

SE-MF-000034517

Manufacturer status

Active

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Primary placement in Italy; available across 7 countries total.

Trade name

SPOT-it TREC, KREC & SMN1 Screening Kit

UDI-DI code

37350134361794

Basic UDI-DI

B-37350134361794

Reference / catalog number

4-2020-TKS

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

SPOT-it™ TREC, KREC & SMN1 Screening Kit is a non-automated in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID), agammaglobulinemia (XLA) and Spinal Muscular Atrophy (SMA) in newborns. SCID and XLA screenings are performed by semi-quantification of T-cell receptor excision circles (TREC) and kappa-deleting recombination excision circles (KREC) and SMA screening by a qualitative detection of exon 7 of the SMN1 gene. DNA is extracted from fresh, dried blood spots (DBS) sampled on filter paper. The principle of the assay is real-time quantitative polymerase chain reaction (qPCR). The test is intended for use by laboratory professionals to aid in identifying newborns who potentially suffer from SCID caused by a lack of mature T- or Tand B-lymphocytes or XLA caused by a selective lack of mature B-lymphocytes or SMA caused by homozygous exon 7 deletion in the SMN1 gene. Diagnosis shall be made by healthcare professionals through confirmatory testing, according to local requirements or recommendations.

Additional information URL

https://www.immunoivd.com/ifu/tks

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