MMI
Access hsTnI
- Advisory panel
- Clinical Chemistry
- Total cleared
- 94
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
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 MMI
- K252393 — VITROS Immunodiagnostic Products hs Troponin I Reagent Pack
- K243483 — Access hsTnI
- K242870 — Access hsTnI
- K240984 — i-STAT hs-TnI cartridge with the i-STAT 1 System
- K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH)
- K231974 — PATHFAST®hs-cTnI-II
- K222881 — Access hsTnI
- K230648 — Access hsTnI
- K230994 — Alinity i STAT High Sensitivity Troponin-I
- K202525 — Alinity i STAT High Sensitivity Troponin-I
- K201441 — Elecsys Troponin T Gen 5
- K191595 — ARCHITECT STAT High Sensitivity Troponin-I
- K190675 — Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
- K182225 — Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
- K171566 — Atellica IM High-Sensitivity Troponin I (TNIH)
- K171274 — ADVIA Centaur High-Sensitivity Troponin I (TNIH)
- K172787 — Access hsTnl
- K172783 — Access hs Tnl
- K162895 — Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
- K121790 — ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
- K121214 — ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM
- K100130 — PATHFAST CTNI-II TEST, PATHFAST CTNI CALIBRATORS, PATHFAST SAMPLE DILUENT 2
- K102131 — NANO-CHECK AMI CTNI CARDIAC MARKER TEST
- K102441 — NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN
- K082699 — ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
- K081643 — DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
- K063243 — VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K063756 — DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
- K062838 — VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
- K060875 — ABBOTT AXSYM TROPONIN-I ADV
- K053577 — DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
- K050975 — NANO-CHECK AMI 3 IN 1 CARDIAC DISEASE TEST FOR CARDIAC TROPONIN I, CREATINE KINASE MB AND MYOGLOBIN
- K053020 — TNL-ULTRA ASSAY FOR THE ADVIA CENTAUR SYSTEM
- K052503 — TROPONIN I ULTRA ASSAY AND CALIBRATOR FOR THE ADVIA IMS SYSTEM
- K051925 — CARESTART CARDIAC 3-IN-1 TROPONIN 1/CK-MB/MYOGLOBIN
- K050644 — VANCOUVER BIOTECH HUMAN CARDIAC TROPONIN I IMMUNOASSAY TEST KIT
- K051752 — ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
- K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
- K042227 — INSTANT-VIEW TROPONIN I TEST
- K041811 — ABBOTT AXSYM TROPONIN-I ADV
- K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY
- K033745 — RAMP TROPONIN I ASSAY
- K040733 — ELECSYS TROPONIN T STAT TEST
- K033487 — STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
- K031031 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK AND CALIBRATORS
- K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST
- K030950 — VIDAS TROPONIN I (TNI), MODEL 30 445
- K023505 — VBL SERUM TROPONIN I TEST, MODEL 1001
- K030057 — SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
- K024193 — MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS
- K022946 — LIFESIGN MI MYOGLOBIN/TROPONIN I RAPID TEST
- K021814 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345
- K020950 — SPECTRAL'S 2 IN 1 (TNI-MYO)
- K020662 — MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/ CALIBRATORS
- K014105 — SPECTRAL'S TROPONIN I
- K013062 — BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
- K014024 — MODIFICATION TO ALPHA DX SYSTEM
- K012820 — AIA-PACK CTNI 2ND-GEN ASSAY
- K010429 — ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345
- K010313 — DIMENSION CTNI FLEX REAGENT CARTRIDGE
- K010201 — BAYER ADVIA IMS SYSTEM
- K010562 — ALPHA DX SYSTEM
- K000784 — THE CARDIAC READER SYSTEM
- K993309 — BAYER DIAGNOSTICS ACS:180 AND ADVIA CENTAUR TROPONIN I ASSAY
- K993353 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
- K992366 — VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
- K992127 — CARDIOQUANT TROPONIN I TEST
- K991177 — OPUS TROPONIN I (CTN) TEST MODULES
- K991795 — IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
- K984359 — AIA-PACK TROPONIN I ASSAY
- K984093 — STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
- K984105 — ELECSYS TROPONIN T STAT TEST
- K983972 — IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
- K981882 — CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
- K981098 — STRATUS CS CARDIAC TROPONIN I TESTPAK
- K980528 — CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)
- K974839 — ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
- K974818 — ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
- K973616 — TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
- K974103 — ABBOTT AXSYM TROPONIN-I
- K974075 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K973650 — TROPONIN (TROP) METHOD
- K972094 — TARGET CARDIAC TROPONIN I TEST
- K964372 — CARDIAC T TROPONIN T RAPID ASSAY
- K964862 — TROPONIN-I TEST SYSTEM
- K963934 — ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBERS: 33320, 33325 AND 33329
- K963513 — CARDIAC STATUS TROPONIN I
- K961500 — ELECSYS TROPONIN T
- K955868 — BOEHRINGER MANNHEIM CARDIAC T TROPNIN T
- K955284 — OPUS TROPONIN I
- K952478 — BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY
- K951890 — STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS
- K924392 — CARDIAC T ELISA TROPONIN-T
Data sourced from openFDA. This site is unofficial and independent of the FDA.