JHI
BIONIKE A/Q PREGNANCY TEST
- Advisory panel
- Clinical Chemistry
- Total cleared
- 375
Adverse events under product code JHI
product code JHI- Malfunction
- 1,055
- Total
- 1,055
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 JHI
1–100 of 375- K241919 — Innovita HCG Pregnancy Rapid Combo Test
- K203272 — Alltest Pregnancy Rapid Combo Test Cassette
- K172322 — Atellica IM Total hCG (ThCG)
- K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
- K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
- K130456 — WUNDER PREGNANCY TEST
- K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST
- K131166 — SOFIA(R) HCG FIA
- K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
- K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
- K112315 — HOME PREGNANCY TEST
- K102175 — RAPIDVUE HCG TEST
- K072264 — FASTPACK HCG IMMUNOASSAY
- K070921 — BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
- K071030 — BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
- K061257 — DBEST HCG PANEL TEST KIT
- K062361 — INNOVACON HCG UKTRA TEST DEVICE
- K050955 — LIFESIGN DXPRESS, MODEL LSR2000
- K052694 — ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
- K051841 — WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
- K050741 — IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
- K043385 — OSOM HCG COMBO TEST
- K041946 — ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
- K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
- K033297 — ZAP HCG TEST, MODEL 8001
- K032563 — CLINITEST HCG PREGNANCY TEST
- K032987 — ACCUTEST HCG-COMBO MODEL,HCG-004, ACCUSTRIP HCG-COMBO MODEL, HCG-005
- K031445 — MAINLINE MAXIE HCG URINE PREGNANCY TEST
- K031048 — CARESTART HCG COMBO ONE-STEP PREGNANCY TEST AND CARESTART PLUS HCG COMBO ONE-STEP PREGNANCY TEST
- K023823 — EASYCUP
- K030430 — POLY STAT SERUM/URINE HCG TEST
- K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
- K023544 — GENZYME CONTRAST II HCG URINE/SERUM TEST
- K023480 — ACCESS TOTAL BHCG
- K022683 — SAS BLOOD/SERUM/URINE/URINE HCG
- K021386 — POLY STAT HCG DIPSTICK TEST
- K020968 — LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
- K020378 — QUPID PLUS E.R.
- K020439 — STATUS HCG SERUM/URINE
- K020799 — QUICKVUE ONE-STEP HCG-URINE
- K020801 — QUICKVUE ONE-STEP HCG-COMBO
- K020438 — SAS VALUE HCG
- K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
- K013702 — VICTORCH HCG TEST STRIP
- K012559 — POLY STAT HCG TEST
- K013194 — UNIMARK HCG COMBO PREGNANCY TEST
- K012284 — WH ACCU TEST PREGNANCY TEST
- K011550 — HCG STAT PAK ULTRA-FAST
- K010522 — SUREVUE URINE HCG
- K010593 — SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
- K003856 — EZ-HCG URINE(PREGNANCY TEST)
- K001215 — DBEST HCG 2 IU/ML TEST KIT
- K994227 — ADVANTAGE HCG TEST (URINE/SERUM)
- K993703 — CLEARVIEW EASY HCG PREGNANCY TEST
- K993203 — ACON ONE STEP PREGNANCY TEST STRIP (URINE)
- K993317 — ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
- K992915 — ONE-STEP DOUBLE-CHEK PREGNANCY TEST
- K992695 — INSURE PRO TEST
- K993065 — ACON COMBO PREGNANCY
- K992397 — ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
- K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
- K990684 — MODIFICATION OF SAS SERUM/URINE HCG
- K990741 — SAS ONE-STEP PREGNANCY
- K991095 — QUICKCARD HCG COMBO TEST, MODEL #9014
- K991067 — MODIFICATION OF: DAVIDSTRIP HCG
- K990578 — OSOM CARD II HCG-URINE TEST, MODEL 102
- K984076 — INSTANT-VIEW PREGNANCY URINE TEST
- K984077 — INSTANT-VIEW PREGNANCY COMBO TEST
- K984079 — INSTANT-VIEW PREGNANCY URINE DIP-STRIP TEST
- K984080 — INSTANT-VIEW PREGNANCY COMBO DIP-STRIP TEST
- K981444 — BIOSTRIP HCG I-ONE STEP PREGNANCY TEST ACCUSTRIP HCG 1-ONE STEP PREGNANCY TEST STRIP
- K981443 — BIOSIGN HCG I - ONE STEP PREGNANCY TEST
- K981838 — ACCUSTRIP HCG-URINE MODEL NUMBER HCG-002
- K981770 — RAPIDHCG PREGNANCY TEST
- K981512 — ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005 & 41025
- K980736 — ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
- K981165 — AIMSTEP COMBO PREGNANCY, 1 TEST, 30 TEST, 50 TEST, 100 TEST
- K974060 — MINISTRIP/ SERUM AND URINE COMBO HCG TEST
- K980896 — QUICKCARD PRO HCG TEST, MODEL 9008
- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
- K974009 — PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
- K980531 — AIMSTEP PREGNANCY
- K980205 — SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
- K974615 — QUICKSTICK PRO HCG TEST
- K974851 — SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST
- K974159 — OSOM HCG-URINE TEST MODEL 101
- K974052 — QUICKVUE SEMI-Q HCG-COMBO
- K973957 — DBEST ONE-STEP HCG SERUM/URINE TEST
- K973841 — QUICKVUE ONE-STEP HCG-COMBO
- K973858 — CARDS Q.S. HCG SERUM/URINE;CONCISE PERFORMANCE PLUS HCG-COMBO
- K973879 — OSOM CARD HCG-URINE TEST
- K972742 — QUICKVUE ONE-STEP HCG-URINE
- K972748 — CARDS Q.S. HCG-URINE; AND CONCISE PERFORMANCE PLUS HCG-URINE
- K971886 — ACCUTEST HCG-URINE
- K971122 — ACCULINE PREGNANCY TEST
- K971209 — CLINITEK HCG TEST STRIPS
- K970424 — EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST
- K964633 — ACCUPACK PREGNANCY TEST
- K965116 — ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
- K965250 — SAS SERUM/URINE HCG
Data sourced from openFDA. This site is unofficial and independent of the FDA.