510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Immucor GTI Diagnostics, Inc.

Waukesha, WI, US

Immucor GTI Diagnostics, Inc. appears in FDA device records in Waukesha, WI. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Immucor GTI Diagnostics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Genetic Testing Institute510(k), enforcement report, recall

510(k) clearance history

FDA records hold 8 510(k) clearances for Immucor GTI Diagnostics, Inc. between 1984 and 2020. The busiest year on record is 2020, with 2. The most recent is 2020, with 2.

Clearances by year, as a table
510(k) clearance decisions for Immucor GTI Diagnostics, Inc., by decision year
YearClearances
19841
19991
20001
20061
20071
20081
20202
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K201570PF4 Enhanced assayLCOSubstantially Equivalent
K201311PF4 IgG assayLCOSubstantially Equivalent
K082205FACTOR VIII ANTIBODY SCREENGGPSubstantially Equivalent
K071781PF4 IGGLCOSubstantially Equivalent
K053559PF4 ENHANCED SOLID PHASE ELISALCOSubstantially Equivalent
K993553GTI-FVIII INHIBITOR ASSAYGGPSubstantially Equivalent
K983379GTI-PF4 ELISALCOSubstantially Equivalent
K841114ALLO-TYPE HUMAN IMMUNOGLOBULIN-DGXSubstantially Equivalent

Registered establishments

FDA registered establishments for Immucor GTI Diagnostics, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21836082183608Immucor GTI Diagnostics, Inc.20925 Crossroads Cir, Waukesha, WI 53186 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1001-2015PF4 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-HAT45) The PF4 IgG assay is an Enzyme Linked Immunosorbent Assay (ELISA). The PF4 IgG ELISA is intended to detect IgG antibodies in human serum that react with Platelet Factor 4 (PF4) when it is complexed to heparin or other polyanionic compounds. The PF4 IgG kit contains all of the reagents necessary to perform the assay.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.Class IITerminated
Z-1022-2013Gen-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 result in significant harm to a patiClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain