BEUDAMED
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    DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISA HBA1C, MODEL K3105A

    FDA 510(k)
    FDA Class 2 ·Hematology

    EMIT 2000 VANCOMYCIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Atellica® CH Diazo Total Bilirubin (D_TBil)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M

    FDA 510(k)
    FDA Class 2 ·Immunology

    Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CONTROL PLASMA P

    FDA 510(k)
    FDA Class 2 ·Hematology

    INNOVANCE D-DIMER, MODEL OPBP09

    FDA 510(k)
    FDA Class 2 ·Hematology

    MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PROTEIN S AC

    FDA 510(k)
    FDA Class 2 ·Hematology

    EMIT 2000 VANCOMYCIN CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LOCI 8 CALIBRATOR, MODEL KC 646

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STRATUS CS ACUTE CARE D-DIMER

    FDA 510(k)
    FDA Class 2 ·Hematology

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VERSANT HCV RNA QUALITATIVE ASSAY/APTIMA HCV RNA QUALITATIVE ASSAY

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    FDA Pre-Market Approval
    FDA Class 2 ·AMPLIFIED MTD (MYCOBACTERIUM TUBERCULOSIS DIRECT) TEST

    Agent, Absorbable Hemostatic, Collagen Based

    FDA Pre-Market Approval
    FDA Class 3 ·COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS