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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 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AutoDELFIA Inhibin A kit | B064-112 | FDA UDI | Class I | Unknown |
| VICTOR EnLite | 1420-0230 | FDA UDI | Class I | Unknown |
| PatientCare | 5002-0130 | FDA UDI | Class I | Active |
| AutoDELFIA hCG kit | B007-101 | FDA UDI | Class II | Active |
| DELFIA hLH Spec kit | A031-101 | FDA UDI | Class I | Active |
| AutoDELFIA Unconjugated Estriol (uE3) kit | B083-C01 | FDA UDI | Class I | Unknown |
| NeoBase 2 Non-derivatized MSMS kit | 3044-001U | FDA UDI | Class II | Active |
| GSP Neonatal Creatine Kinase -MM kit | 3311-001U | FDA UDI | Class II | Active |
| AutoDELFIA Neonatal 17α-OH-progesterone kit | B024-01C | FDA UDI | Class I | Unknown |
| GSP Neonatal Thyroxine (T4) kit | 3302-001U | FDA UDI | Class II | Active |
| VICTOR EnLite | 1420-0220 | FDA UDI | Class I | Unknown |
| NeoLSD MSMS kit | 3093-004U | FDA UDI | Class II | Active |
| Victor2 D | 1420-021 | FDA UDI | Class I | Unknown |
| AutoDELFIA Neonatal IRT kit | B005-212 | FDA UDI | Class I | Active |
| NeoGram Derivatized Assay Solutions | 3030-0020 | FDA UDI | Class II | Unknown |
| AutoDELFIA Unconjugated Estriol (uE3) kit | B095-101U | FDA UDI | Class I | Active |
| AutoDELFIA hCG kit | B007-112 | FDA UDI | Class II | Unknown |
| Buffer M | 4402-0010 | FDA UDI | Class I | Active |
| DELFIA Diluent II | B138-100 | FDA UDI | Class I | Active |
| Wallac Plate Shake | 1296-004 | FDA UDI | Class I | Active |
| GSP Neonatal Biotinidase kit | 3307-001U | FDA UDI | Class II | Active |
| DELFIA Diluent I | B128-100 | FDA UDI | Class I | Unknown |
| DELFIA Platewash | 1296-026 | FDA UDI | Class I | Active |
| AutoDELFIA Unconjugated Estriol (uE3) kit | B083-212 | FDA UDI | Class I | Unknown |
| GSP Neonatal Total Galactose Kit | 3309-001U | FDA UDI | Class I | Unknown |
| GSP Neonatal GALT kit | 3303-001U | FDA UDI | Class II | Active |
| AutoDELFIA Neonatal hTSH kit | B032-02C | FDA UDI | Class II | Unknown |
| AutoDELFIA Plate processor | 1235-0110 | FDA UDI | Class I | Active |
| GSP Neonatal IRT kit | 3306-001U | FDA UDI | Class I | Active |
| NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit | 3026-0030 | FDA UDI | Class II | Unknown |
| NeoLSD MSMS kit | 3093-001U | FDA UDI | Class II | Active |
| DELFIA hFSH kit | A017-201 | FDA UDI | Class I | Unknown |
| AutoDELFIA Neonatal IRT kit | B005-204 | FDA UDI | Class I | Unknown |
| GSP Neonatal 17α-OH-progesterone kit | 3305-001U | FDA UDI | Class I | Active |
| AutoDELFIA Neonatal Thyroxine (T4) kit | B065-01C | FDA UDI | Class II | Unknown |
| DELFIA Diluent I | B127-100 | FDA UDI | Class I | Unknown |
| AutoDELFIA Neonatal 17α-OH-progesterone kit | B024-104 | FDA UDI | Class I | Active |
| DELFIA hCG kit | A007-101 | FDA UDI | Class II | Unknown |
| AutoDELFIA Unconjugated Estriol (uE3) kit | B095-112 | FDA UDI | Class I | Unknown |
| Neonatal Biotinidase kit | 3018-0010 | FDA UDI | Class II | Active |
| Wallac DBS Puncher | 1296-071 | FDA UDI | Class I | Active |
| Eonis SCID-SMA kit | 3242-001U | FDA UDI | Class II | Active |
| EVOYA Platform | 5021-1000 | FDA UDI | Class I | Active |
| GSP Neonatal Total Galactose kit | 3309-002U | FDA UDI | Class I | Active |
| EnLite Neonatal TREC kit | 3402-001U | FDA UDI | Class II | Active |
| EnLite Neonatal TREC kit | 3401-001U | FDA UDI | Class II | Active |
| AutoDELFIA hAFP Kit | B079-201 | FDA UDI | Class III | Unknown |
| EnLite Neonatal TREC kit | 3403-001U | FDA UDI | Class II | Active |
| DBS Controls LysoPC | 3413-0010 | FDA UDI | Class I | Active |
| NeoBase Non-derivatized MSMS kit | 3040-001U | FDA UDI | Class II | Active |
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