The Binding Site
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United KingdomLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Thermo Fisher ScientificLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
- 510(k) clearances: 125
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Jan 24, 2024 | Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitK231290 · DFH | 510(k) clearances |
| Mar 18, 2014 | HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNIIK140105 · OPX | 510(k) clearances |
| Dec 20, 2013 | HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KITK132555 · PCN | 510(k) clearances |
| Feb 27, 2012 | HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUSK103824 · CFN | 510(k) clearances |
| Sep 3, 2010 | SPAPLUS ANALYZERK100455 · DBI | 510(k) clearances |
| Dec 30, 2009 | HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P)K090920 · CFN | 510(k) clearances |
| Dec 28, 2009 | HUMAN IGD KIT FOR USE ON SPAPLUSK092450 · CZJ | 510(k) clearances |
| May 6, 2009 | HUMAN BETA-2 MICROGLOBULIN KITK083289 · JZG | 510(k) clearances |
Names and Identifiers
- Appears as
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built