Eu Ivdd
Eu Ivd General
On The Market
🇫🇮 Finland
NeoNat SMA Real-Time PCR Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06438172310032
- Basic UDI-DI Code
- B-06438172310032
- Reference
- 8100463
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
Labsystems Diagnostics’ NeoNat SMA is a Real-Time PCR kit for the screening of Spinal Muscular Atrophy (SMA) by measuring SMN1 (Survival Motor Neuron 1), and SMN2 (Survival Motor Neuron 2) in newborn’s DNA extracted from dried blood spots 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. 480 reactions package
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010299 | POLYGENETIC DISORDERS TESTS - OTHER |
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