BEUDAMED
    Product Code: JBD FDA class 2 21 CFR 864.7440

    System, Analysis, Electrophoretic Hemoglobin

    Hematology

    An electrophoretic hemoglobin analysis system is a laboratory device used to separate and identify different hemoglobin variants in patient blood samples by applying an electric field across a support medium, enabling detection of conditions such as sickle cell disease, thalassemia, and other hemoglobinopathies. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance before marketing. The product code is JBD, regulated under 21 CFR 864.7440, within the Hematology medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    26
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    9
    Years Active
    29

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    Basic Information

    Product Code
    JBD
    Device Class
    FDA class 2
    Regulation Number
    864.7440
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    1

    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 26 510(k) clearances via K numbers.

    K Number Device Name
    K053571 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K032862 INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
    K992199 ACID HEMOGLOBIN KIT
    K991362 HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
    K982426 SPIFE ALKALINE HEMOGLOBIN
    K931503 REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
    K931465 REP ALKALINE HB-15 #3196,-8 #3197,-4 3198
    K901143 REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)
    K830804 LABILE REMOVING HEMOLYZING REAGENT
    K820518 GELMAN GLYCO-PHORE BUFFER
    K813395 CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
    K810919 HEMOGLOBIN ELECTROPHORESIS CONTROL
    K810047 AUTOPHOR 128
    K802884 CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
    K802821 PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
    K800856 A,FDA2 LYOPHILIZED HEMO CONTROL
    K800855 A,FSC LYOPHILIZED HEMO CONTROL
    K800854 A,A2 LYOPHILIZED HEMO CONTROL
    K800853 A,SA2 LYOPHILIZED HEMO CONTROL
    K791290 BECKMAN B-4 TEB BUFFER KIT
    K791008 ECA (SPECIAL) HEME BUFFER
    K790944 CITRATE AGAR GEL AND BUFFER SET
    K781119 ECA HEME BUFFER
    K780807 HBF-QUIPLATE METHODOLOGY
    K780163 REDI-DISC HEMOGLOBIN GEL TUBE KIT
    K771649 HEMOGLOBIN A2 TESTING SYSTEM

    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.