Dade Behring, Inc.
FDA 510(k) medical device clearances.
Clearances by Dade Behring, Inc. — page 2
101–200 of 343- K061751 — DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260
- K061655 — DIMENSION VISTA FLEX REAGENT CARTRIDGES
- K061702 — DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340)
- K061338 — DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
- K061390 — DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
- K061218 — DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
- K061503 — DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
- K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
- K061238 — DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE
- K053337 — DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
- K060502 — DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
- K060503 — DIMENSION TACR CALIBRATOR, MODEL DC107
- K061020 — DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE
- K060369 — STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
- K053577 — DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT
- K060385 — EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
- K060548 — STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK
- K060628 — DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
- K052788 — N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
- K053072 — N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN
- K053073 — N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
- K060312 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)
- K053074 — N ANTISERA TO HUMAN CERULOPLASMIN
- K053075 — N ANTISERA TO HUMAN TRANSFERRIN
- K060266 — DIMENSION IRON CALIBRATOR
- K060371 — THE EMIT 2000 TACROLIMUS CALIBRATORS
- K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
- K053531 — DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR
- K060090 — DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE
- K053504 — MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)
- K053108 — DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108
- K053576 — DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR
- K053061 — EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY
- K060088 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN
- K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
- K053109 — DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
- K053157 — AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
- K052346 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
- K052015 — DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108
- K051650 — STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.
- K052017 — CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108
- K051597 — STRATUS CS D-DIMER
- K051478 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN
- K051350 — SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS
- K051311 — MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN
- K051087 — DIMENSION VISTA INTEGRATED SYSTEM
- K050928 — DADE THROMBIN REAGENT
- K051202 — DRIED GRAM-POSITIVE MIC/COMBO PANELS
- K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
- K050043 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
- K050585 — MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
- K043545 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
- K042735 — N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
- K043476 — STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT
- K043546 — DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
- K043028 — EMIT II PLUS ECSTASY ASSAY
- K042687 — ENZYGNOST F+2 (MONOCLONAL) TEST KIT
- K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
- K042333 — CONTROL PLASMA N, PROC CONTROL PLASMA
- K042347 — MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
- K042407 — EMIT CAFFEINE ASSAY
- K042209 — CONTROL PLASMA N AND CONTROL PLASMA P
- K041878 — N LATEX CYSTATIN
- K041438 — ADVANCED D-DIMER ASSAY
- K041870 — N APOLIPOPROTEIN STANDARD SERUM
- K041150 — MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS
- K041417 — DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423
- K040133 — URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
- K031601 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)
- K033948 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
- K033940 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
- K033809 — DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D
- K032706 — MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML
- K033713 — URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
- K033908 — N HIGH SENSITIVITY CRP
- K033525 — DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
- K033487 — STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
- K033482 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)
- K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
- K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111
- K032573 — DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
- K032798 — DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A
- K032574 — DIMENSION DRUG CALIBRATOR II, MODEL DC49C
- K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
- K032237 — N/T PROTEIN CONTROL
- K032014 — N LATEX IGM
- K031602 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)
- K031512 — EMIT II PLUS COCAINE METABOLITE ASSAY
- K031004 — SYVA EMIT II PLUS AMPHETAMINES ASSAY
- K031135 — GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
- K031343 — TPSA FLEX REAGENT CARTRIDGE
- K024038 — N LATEX IGA
- K022976 — STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
- K023141 — MODIFICATION TO STANDARD HUMAN PLASMA
- K023361 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)
- K023541 — MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)
- K022977 — STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
- K023309 — CONTROL PLASMA N
- K023312 — CONTROL PLASMA P
- K023065 — CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.