Genetic Testing Institute,inc
FDA Regulatory Profile
Genetic Testing Institute,inc appears in FDA public data with 2 recalls, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1001-2015, Class II) was initiated on December 15, 2014. Its most recent 510(k) clearance was granted on November 20, 2008.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 6
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1001-2015 | Class II | PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIF | December 15, 2014 |
| Z-1022-2013 | Class II | Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a sol | February 4, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K082205 | FACTOR VIII ANTIBODY SCREEN | November 20, 2008 |
| K071781 | PF4 IGG | December 19, 2007 |
| K053559 | PF4 ENHANCED SOLID PHASE ELISA | January 20, 2006 |
| K993553 | GTI-FVIII INHIBITOR ASSAY | February 1, 2000 |
| K983379 | GTI-PF4 ELISA | March 9, 1999 |
| K841114 | ALLO-TYPE HUMAN IMMUNOGLOBULIN- | June 14, 1984 |