Diagnostics makerLabelled by claude-haiku-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.
As of Nov 15, 2026, FDA's public records list Genetic Testing Institute with 6 510(k) clearances and 2 device recalls. The most recent is a device recall dated Dec 15, 2014: PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. Immu….
| Dec 15, 2014 | PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, Class II · Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased O | Device recalls |
| Feb 4, 2013 | Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assClass II · Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values wh | Device recalls |
| Nov 20, 2008 | FACTOR VIII ANTIBODY SCREENK082205 · GGP | 510(k) clearances |
| Dec 19, 2007 | PF4 IGGK071781 · LCO | 510(k) clearances |
| Jan 20, 2006 | PF4 ENHANCED SOLID PHASE ELISAK053559 · LCO | 510(k) clearances |
| Feb 1, 2000 | GTI-FVIII INHIBITOR ASSAYK993553 · GGP | 510(k) clearances |
| Mar 9, 1999 | GTI-PF4 ELISAK983379 · LCO | 510(k) clearances |
| Jun 14, 1984 | ALLO-TYPE HUMAN IMMUNOGLOBULIN-K841114 · DGX | 510(k) clearances |
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
