4-2020-TS

Organization name

ImmunoIVD AB

SRN

SE-MF-000034517

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.

Primary placement in Sweden; available across 31 countries total.

Trade name

not provided

UDI-DI code

37350134361787

Basic UDI-DI

7350134361789C

Reference / catalog number

4-2020-TS

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

4

Additional product description

SPOT-it™ TREC & SMN1 Screening Kit is a non-automated in vitro diagnostic kit intended for simultaneous screening for severe combined immunodeficiency (SCID) and Spinal Muscular Atrophy (SMA) in newborns. SCID screening is performed by semiquantification of T-cell receptor excision circle (TREC) 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-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/ts

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