SPOT-it TREC & KREC Screening Kit

Organization name

ImmunoIVD AB

SRN

SE-MF-000034517

Manufacturer status

Active

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Primary placement in Sweden; available across 6 countries total.

Trade name

SPOT-it TREC & KREC Screening Kit

UDI-DI code

47350134361180

Basic UDI-DI

B-47350134361180

Reference / catalog number

12-2015-TK

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 Screening Kit is a non-automated in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID) and agammaglobulinemia (XLA) in newborns. SCID and XLA screenings are performed by semi-quantification of T-cell receptor excision circle (TREC) and kappa-deleting recombination excision circles (KREC). 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 T- and B-lymphocytes or XLA caused by a selective lack of mature B-lymphocytes. Diagnosis shall be made by healthcare professionals through confirmatory testing, according to local requirements or recommendations.

Additional information URL

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

Clinical sizes

No clinical sizes registered for this device.

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• Expiration date
• Manufacturing date
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European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0106010199MONOGENETIC DISORDERS TESTS - OTHER