CEW
ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
- Advisory panel
- Clinical Chemistry
- Total cleared
- 86
Adverse events under product code CEW
product code CEW- Malfunction
- 480
- Total
- 480
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 CEW
- K231927 — Elecsys PTH , Elecsys PTH STAT
- K232791 — Access Intact PTH
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K190702 — Lumipulse G whole PTH
- K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay
- K161158 — IDS-iSYS Intact PTHN
- K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
- K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY
- K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
- K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
- K103325 — IDS-ISYS INTACT PTH
- K101921 — VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT
- K070709 — ROCHE ELECSYS PTH TEST SYSTEM
- K063605 — ST AIA-PACK INTACT PTH ASSAY
- K063232 — ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
- K070391 — ELECSYS PTH TEST SYSTEM
- K061190 — ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
- K060420 — MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002
- K060348 — MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
- K053533 — IMMULITE/IMMULITE 1000 TURBO INTACT PTH
- K051888 — TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
- K051810 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
- K051141 — WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
- K051150 — TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
- K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
- K033727 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY
- K033426 — LIAISON N-TACT PTH
- K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
- K031534 — CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
- K022472 — PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84)
- K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER
- K020945 — AXSYM INTACT PTH, MODEL 2G06
- K013992 — NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
- K013566 — IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
- K011505 — IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
- K004038 — TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
- K001411 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056
- K000471 — FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
- K992680 — ELECSYS PARATHYROID HORMONE TEST SYSTEM
- K992105 — IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
- K974306 — SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA
- K973514 — ACTIVE INTACT PTH
- K970483 — AQUALITE INTACT PTH
- K962598 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
- K962033 — CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
- K954418 — INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
- K944788 — INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
- K952199 — ACTIVE INTACT PTH ELISA
- K950211 — ELSA-PTH
- K942369 — GAMMA-BCT INTACT PTH
- K941878 — OCTEIA INTACT PTH
- K934760 — IMMUNLITE INTACT PTH
- K930008 — COAT-A-COUNT INTACT PTH IRMA
- K921949 — COTUBE PTH IRMA
- K921629 — N-TACT(R) PTH SP KIT
- K913434 — VENTREX COATED TUBE INTACT PTH
- K903130 — LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY
- K901711 — PTH-MM II 125I RADIOIMMUNOASSAY (RIA)
- K896294 — DSL I-PTH (DSL #8000)
- K882560 — CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
- K874299 — N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
- K871970 — DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
- K861797 — ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
- K853784 — C-TERMINAL PTH RIA KIT
- K844735 — PTH-RIA
- K850254 — PARATHYROID HORMONE RADIOIMMUNOASSAY KIT
- K843870 — PARATHYROID HORMONE MID-MOLECULE RIA-KIT
- K843871 — PARATHYROID HORMONE C-TERMINAL RIA KIT
- K843685 — C-TERMINAL/MID-MOLECULE PARATHYROID -
- K840379 — PARATHYROID HORMONE ANALYSIS PRODUCT
- K833768 — C. PTH RADIOIMMUNOASSAY KIT-CPTHK
- K831470 — PTH MR
- K831069 — DAC-CEL PTH KIT RD51
- K830664 — HUMAN INTRACT PARATHYROID HORMONE BY
- K830700 — MMH PTH RIA KIT
- K822944 — GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT
- K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID
- K820228 — MIN-MOLECULE PTH BY RADIOIMMUNOASSAY
- K813203 — C-TERMINAL PTH RIA TEST KIT, DSL-1000
- K811566 — C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT
- K811418 — N-TERMINAL HPTH BY RIA
- K791128 — PTH RIA 200
- K782081 — RIA SYSTEM, PARATHYROID HORMONE
- K782010 — HORMONE KIT, PARATHYROID
- K772249 — COMPLEMENT C3 NEPHELOMETRIC ASSAY
- K771783 — PTH RIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.