BEUDAMED
    Product Code: GJT FDA class 2 21 CFR 864.7290

    Plasma, Coagulation Factor Deficient

    Hematology

    Plasma, Coagulation Factor Deficient (product code GJT) is a hematology reference plasma that lacks one or more specific coagulation factors, used as a substrate in factor assays to detect and quantify factor deficiencies in patients with bleeding disorders. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7290 in the Hematology specialty (HE), it is eligible for third-party review.

    View on FDA
    510(k)s
    79
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    20
    Years Active
    36

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    Basic Information

    Product Code
    GJT
    Device Class
    FDA class 2
    Regulation Number
    864.7290
    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 79 510(k) clearances via K numbers.

    K Number Device Name
    K222831 CRYOcheck Factor VIII Deficient Plasma with VWF
    K180486 HemosIL Factor XII Deficient Plasma
    K102908 NOFACT IX
    K102851 NOFACT VIII
    K110237 HEMOSIL FACTOR VIII DEFICIENT PLASMA
    K050661 HEMOSIL FACTOR II DEFICIENT PLASMA
    K043459 HEMOSIL FACTOR XII DEFICIENT PLASMA
    K040362 DIAPHARMA FACTOR X KIT
    K034007 HEMOSIL FACTOR VIII DEFICIENT PLASMA
    K031829 HEMOSIL FACTOR IX DEFICIENT PLASMA
    K031122 HEMOSIL FACTOR X DEFICIENT PLASMA
    K030287 HEMOSIL FACTOR XI DEFICIENT PLASMA
    K024082 HEMOSIL FACTOR VII DEFICIENT PLASMA
    K023839 HEMOSIL FACTOR V DEFICIENT PLASMA
    K990814 CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
    K990296 CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
    K990046 PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
    K981174 CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
    K981173 CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
    K981709 COAGULATION FACTOR V DEFICIENT PLASMA
    K972627 PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
    K971223 CRYO CHECK FACTOR V DEFICIENT PLASMA
    K971227 CRYO CHECK FACTOR X DEFICIENT PLASMA
    K971226 CRYO CHECK FACTOR IX DEFICIENT PLASMA
    K971225 CRYO CHECK FACTOR VIII DEFICIENT PLASMA
    K971224 CRYO CHECK FACTOR VII DEFICIENT PLASMA
    K972286 FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
    K970607 UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
    K970593 UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
    K962675 STA - LIATEST VWF TEST KIT
    K962671 STA-VWF CALIBRATOR KIT
    K945857 PROTEIN C DEFICIENT PLASMA
    K942050 HEMOLAB COFAC IX
    K942049 BIOMERIEUX HEMOLAB COFAC II
    K935851 BIOMERIEUX HEMOLAB COFAC X
    K935850 BIOMERIEUX HEMOLAB COFAC VII
    K935057 FACTOR VIII DEFICIENT PLASMA
    K935058 FACTOR
    K935056 FACTOR VII DEFICIENT PLASMA
    K935054 FACTOR X DEFICIENT PLASMA
    K934606 STAGO FACTOR II-DEFICIENT PLASMA
    K934605 STAGO FACTOR V-DEFICIENT PLASMA
    K933432 STAGO FACTOR IX-DEFICIENT PLASMA
    K933444 STAGO FACTOR XI-DEFICIENT PLASMA
    K933441 STAGO FACTOR X-DEFICIENT PLASMA
    K933440 STAGO FACTOR VII-DEFICIENT PLASMA
    K933438 STAGO FACTOR XII-DEFICIENT PLASMA
    K933010 BIOMERIEUX HEMOLAB COFAC VIII
    K924400 CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA
    K924396 CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
    K924394 CLOTTING FACTOR V DEFICIENT PLASMA
    K915411 DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA
    K912679 DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
    K902083 CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE
    K901327 ORTHO CORRECTION REAGENTS
    K900906 FACTOR II DEFICIENT PLASMA
    K900412 FACTOR XII DEFICIENT PLASMA
    K900411 FACTOR XI DEFICIENT PLASMA
    K900410 FACTOR X DEFICIENT PLASMA
    K900409 FACTOR IX DEFICIENT PLASMA
    K900408 FACTOR VIII DEFICIENT PLASMA
    K900407 FACTOR VII DEFICIENT PLASMA
    K900406 FACTOR V DEFICIENT PLASMA
    K900133 FACTOR II DEFICIENT PLASMA
    K895504 ABNORMAL REFERENCE PLASMA-IX
    K895503 ABNORMAL REFERENCE PLASMA-VIII
    K893536 FACTOR XI DEFICIENT PLASMA
    K893535 FACTOR VII DEFICIENT PLASMA
    K893534 FACTOR XII DEFICIENT PLASMA
    K893533 FACTOR V DEFICIENT PLASMA
    K893525 FACTOR VIII DEFICIENT PLASMA
    K893524 FACTOR IX DEFICIENT PLASMA
    K893523 FACTOR X DEFICIENT PLASMA
    K883692 ORTHO FACTOR VII DEFICIENT PLASMA
    K883691 ORTHO FACTOR XI DEFICIENT PLASMA
    K883690 ORTHO FACTOR X DEFICIENT PLASMA
    K883688 ORTHO FACTOR XII DEFICIENT PLASMA
    K880874 IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
    K880292 FACTOR VIII REFERENCE PLASMA

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.