Data / Medical devices / United States / Immucor GTI Diagnostics, Inc.
Immucor GTI Diagnostics, Inc.: FDA-registered device maker in Waukesha, WI, United States, 3 510(k) clearances
Immucor GTI Diagnostics, Inc. is registered with the FDA (registration 2183608) in Waukesha, WI, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 11, 2020. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183608
- Address
- 20925 Crossroads Cir, Waukesha, WI, United States, 53186
- Owner or operator
- IMMUCOR, INC. (1034569)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- April 15, 2013
- Registered through
- 2026
- Brand names listed
- Concentrated Wash (10X), DonorScreen-HLA Class I and Class II, DonorScreen-HLA Class I and Class II Additional Reagents, Factor VIII Antibody Screen, LIFECODES C3d Detection, LIFECODES HLA-A SSO Typing Kit, LIFECODES HLA-A eRES SSO Typing Kit, LIFECODES HLA-B SSO Typing Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| General Purpose Reagent | PPM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Platelet Factor 4 Radioimmunoassay | LCO | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Test, Platelet Antibody | MYP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative, For Hla, Non-Diagnostic | MZI | U | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2020 | K201570 | PF4 Enhanced assay | LCO | Substantially Equivalent | Immucor Gti Diagnostics, Inc. | accessdata.fda.gov |
| June 18, 2020 | K201311 | PF4 IgG assay | LCO | Substantially Equivalent | Immucor Gti Diagnostics, Inc. | accessdata.fda.gov |
| November 20, 2008 | K082205 | FACTOR VIII ANTIBODY SCREEN | GGP | Substantially Equivalent | Genetic Testing Institute | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 15, 2014 | 70012 | Class II | Terminated | PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and 2. ImmucorGamma LIFECODES PF4 Enhanced (catalog numbers X-HAT13, X-HAT | Some Lots of PF4 Concentrated Wash (10X) are a slightly more dilute concentration. This may lead to slightly increased Optical Density (OD) values. Samples with a higher background reactivity may demonstrate false positive result (borderline reactivity) at or near the cutoff for the assay. | accessdata.fda.gov |
| February 4, 2013 | 64501 | Class II | Terminated | Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45 GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). | Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Qualitative, For Hla, Non-Diagnostic
- All makers of General Purpose Reagent
- All makers of Platelet Factor 4 Radioimmunoassay
- All makers of Test, Qualitative And Quantitative Factor Deficiency
Updated September 11, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.