GTY
SAS STREPALERT
- Advisory panel
- Microbiology
- Total cleared
- 43
Adverse events under product code GTY
product code GTY- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GTY
- K251697 — Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip
- K212623 — Healgen Strep A Rapid Test Strip (Throat Swab)
- K171976 — Sofia Strep A+ FIA, Sofia 2 Analyzer
- K141775 — SOFIA (R) STREP A+ FIA
- K133343 — WONDFO RAPID STREP A TEST
- K123793 — SOFIA STREP A FIA
- K122718 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF GROUP A STREP
- K091489 — CLEARVIEW ADVANCED STREP A , MODEL 737-430
- K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
- K051638 — INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
- K040708 — STATUS FIRST STREP A
- K031784 — ACON STREP A RAPID TEST DEVICE
- K023766 — ACON STREP A TWIST TEST DEVICE
- K023270 — SAS STREPALERT
- K013379 — SAS STREPALERT
- K011097 — QUICKVUE DIPSTICK STREP A
- K010582 — ACON STREP A RAPID TEST STRIP
- K993456 — SAS STREP A TEST
- K992658 — OSOM ULTRA STREP A TEST, MODEL 147
- K991828 — STREP B OIA
- K982373 — UNI-GOLD STREP A TEST KIT
- K983386 — BIOSTREP A-DIRECT STREP A ANTIGEN TEST
- K971349 — BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
- K945080 — QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
- K936112 — STREP B OIA
- K935667 — QTEST(R) STREP
- K922765 — BIOSTARS STREP A OIA -- MODIFICATION
- K922490 — ABBOTT STREP A CONTROLS
- K905020 — SLIDEX STREPTO-KIT
- K904589 — KODAK SURECELL(TM) STREP A CONTROL FLUID SET
- K902991 — ICON STREP B IMMUNOENZYMETRIC ASSAY
- K882811 — STREPSLIDE
- K864752 — ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
- K862475 — RESPIRASTICK ENZYME IMMUNOASSAY TEST
- K862133 — HYGEIA RAPID STREP A TEST
- K861575 — DIRECTATEX STREP A
- K840511 — STREPTOCOCCUS GR. D
- K840512 — STREPTOCOCCUS PNEUMONIAE CONTROL
- K840513 — STREPTOCOCCUS GR. B CONTROL
- K840048 — PHADEBACT CSF POSITIVE CONTROLS
- K832248 — PHADEBACT STREP POSITIVE CONTROLS
- K831599 — MERITEC-STREP GROUP A BETA-HEMOLYTIC
- K812808 — BBL DIRECTIGEN TEST KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.