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Organization name
UDI-DI code
Reference / catalog number

8100481 — IVDD — General IVDD by Labsystems Diagnostics Oy

MD Atlas
Labsystems Diagnostics Oy

EUDAMED last updated this device on Aug 5, 2024

8100481

B-06438172311015

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Labsystems Diagnostics Oy
UDI-DI code: 06438172311015
Reference / catalog number: 8100481

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Manufacturer information

Organization name: Labsystems Diagnostics Oy
SRN: FI-MF-000018281
Manufacturer status: Active

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

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

CW008
EUDAMED did not publish a description for this code.
CW263
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

Placed on the market in Finland; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 06438172311015
Basic UDI-DI: B-06438172311015
Reference / catalog number: 8100481
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Labsystems Diagnostics’ NeoNat SCID-SMA Real-Time PCR Kit is a Real-Time PCR kit for the screening of Severe Combined Immunodeficiency (SCID) by semi quantitative determination of TREC (T-cell Receptor Excision Circle), & KREC (Kappa-deleting Recombination Excision Circle), Spinal Muscular Atrophy (SMA) by measuring SMN1 (Survival Motor Neuron 1), & SMN2 (Survival Motor Neuron 2) and X-linked agammaglobulinemia (XLA) in newborn’s DNA extracted from DBS samples. This assay should only be used in conjunction with other clinical and confirmatory laboratory findings and results from this test alone should not be used to make diagnostic or treatment decisions. 96 reactions package
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0106010299POLYGENETIC DISORDERS TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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