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Sign in to claim this brandWhat Wallac, Inc. makes
Wallac, Inc. manufactures laboratory diagnostic tools, including fluorescent immunoassay analysers for clinical testing, as well as kits for nucleic acid techniques like T-cell receptor excision circle (TREC) analysis. Their portfolio also includes enzyme-based immunoassay controls for clinical chemistry, buffered sample diluents, and assay development reagents for specific analytes. Additionally, they produce mass spectrometry-based kits for amino acid and carnitine metabolite testing, as well as enzyme fluorescence kits for conditions like biotinidase deficiency.
The company’s devices are regulated under FDA classifications including Class I, Class II, and Class III, with some products authorised via the 510(k) pathway and others under the De Novo and Premarket Approval (PMA) routes. These products are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases, reflecting their compliance with US regulatory requirements. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
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Catalogue (65)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GSP Neonatal hTSH kit | 3301-001U | FDA UDI | Class II | Active |
| AutoDELFIA Sample processor | 1297-0110 | FDA UDI | Class I | Active |
| AutoDELFIA Sample Processor | 1297-014 | FDA UDI | Class I | Active |
| DBS Controls M2 | 3255-0010 | FDA UDI | Class I | Active |
| Eonis SCID-SMA kit | 3241-001U | FDA UDI | Class II | Active |
| Eonis DNA Extraction kit | 3240-001U | FDA UDI | Class I | Active |
| Specimen Gate Laboratory | 5002-0180 | FDA UDI | Class I | Active |
| LysoPC IS | 4417-0010 | FDA UDI | Class I | Active |
| AutoDELFIA Plate Processor | 1235-001 | FDA UDI | Class I | Active |
| AutoDELFIA Inhibin A kit Level Calibrators | B064-112-P2 | FDA UDI | Class I | Active |
| Iduronate 2-sulfatase S&IS | 4400-0010 | FDA UDI | Class I | Active |
| Screening Center | 5002-0500 | FDA UDI | Class I | Active |
| AutoDELFIA hAFP kit | B079-212 | FDA UDI | Class III | Active |
| Wallac Neonatal Leucine Test Kit Model Nl-1000 | K982307 | FDA 510(k) | Class II | Active |
| Wallac Neonatal Biotinidase Test Kit, Models Nb-1000; Nb-4000 | DEN990008 | FDA 510(k) | Class II | Active |
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