BEUDAMED
    Product Code: CFE FDA class 2 21 CFR 862.1445

    Electrophoretic, Lactate Dehydrogenase Isoenzymes

    Clinical Chemistry

    The Electrophoretic Lactate Dehydrogenase Isoenzymes Test is a clinical chemistry device that uses electrophoresis to separate the five LDH isoenzyme fractions based on their different electrical charges, enabling identification of the tissue source of elevated LDH activity and improving diagnostic specificity for cardiac, hepatic, and other organ-specific injuries. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CFE, regulated under 21 CFR 862.1445, within the Clinical Chemistry medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    28
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    12
    Years Active
    33

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    Basic Information

    Product Code
    CFE
    Device Class
    FDA class 2
    Regulation Number
    862.1445
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 28 510(k) clearances via K numbers.

    K Number Device Name
    K100307 GELSCAN, MODEL 1206
    K022455 SPIFE LD-12 KIT, MODEL 3338
    K020467 SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
    K970477 HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
    K940224 CARDIO REP LD
    K921455 ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
    K905861 ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
    K894081 ROCHO ISOMUNE - LD
    K892818 REP(TM) LD-2 STAT KIT, CAT. NO. 3078
    K874145 TITAN GEL REP LDH-6 HV
    K874142 TITAN GEL REP LDH-30 HV
    K874143 TITAN GEL REP LDH-12 HV
    K873386 TITAN GEL LDH REP SYSTEM
    K861750 CK/LD BUFFER (CAT. NO. 5808)
    K850210 ISOENZYME TEST LD-1
    K842669 TITAN GEL ISO DOT LDH KIT
    K841433 CORNING LACTATE DEHYDROPHORETIC ASSAY
    K832314 CARDIZYME PLUS LD #65094/93
    K830872 TITAN GEL LDH ISO-ENZYME CONTROL
    K802628 PARAGON ELECTROPHORESIS LACTATE REAG.KIT
    K800568 TRANSPHOR TM LD LACTATE DEHYDROGENASE
    K791373 ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS
    K791827 LDH CLINI GEL KIT
    K791657 LDH ISOENZYME REAGENT
    K791656 ENZYME STABILIZING REAGENT (ESR)
    K790311 LDH ISOENZYME REAGENT
    K781125 LDH ISOENZYME REAGENT
    K780080 LACTATE DEHYDROGENASE COLORIMETRIC SUB.

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.