NeoNat SCID-SMA Multiplex Real-Time PCR Kit
Basic Information
- Primary DI
- 06438172308022
- Basic UDI-DI Code
- B-06438172308022
- Reference
- 8100412
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Labsystems Diagnostics Oy
Additional Description
Labsystems Diagnostics’ NeoNat SCID-SMA Multiplex 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) and 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. 192 reactions package
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0106010299 | POLYGENETIC DISORDERS TESTS - OTHER |
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