BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Accriva Diagnostics, Inc.

    Reg #: 3002721930 · FEI: 2250033 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    96
    Establishment Types
    3
    Classifications
    14

    Registration Details

    Registration Name
    Accriva Diagnostics, Inc.
    Registration Number
    3002721930
    FEI Number
    2250033
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6260 Sequence Drive
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992531

    Owner / Operator

    Firm Name
    Accriva Diagnostics, Inc.
    Operator Number
    10048042
    Address
    6260 Sequence Drive
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Paula Morgan

    Products

    Device Name Product Code
    System, Automated Platelet Aggregation JOZ
    Assay, Heparin KFF
    Test, Time, Prothrombin GJS
    System, Multipurpose For In Vitro Coagulation Studies JPA
    Instrument, Coagulation KQG
    Oximeter DQA
    Activated Whole Blood Clotting Time JBP
    Plasma, Coagulation Control GGN
    Device, Bleeding Time JCA
    Protamine Sulphate GFT
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Fiber, Medical, Absorbent FRL
    Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide JKS
    Activated Partial Thromboplastin GFO

    Proprietary Names

    86000 - VerifyNow Instrument 85063 - Validation Kit 86000D - VerifyNow Instrument 85047 - WQC 86000L - VerifyNow Instrument 86003D - VerifyNow Instrument 86000RF - VerifyNow Instrument 86003L - VerifyNow Instrument 70068 - EQC 86003 - VerifyNow Instrument 85062 - Preventative Maintenance Kit 85053 - Aspirin Test 85053-10 - Aspirin Test 85225 - PRUTest 85065 - VerifyNow System, International 85066 - VerifyNow System, International RQCHRT - RxDx Whole Blood Quality Control Heparin R-HRT480P - Heparin Response Test J201 - PT Cuvettes HRS.110 - Hemochron Response Instrument HRS.RF - Hemochron Response Instrument HRS.110L - Hemochron Response Instrument HRS.110D - Hemochron Response Instrument AVOX1000E - Whole Blood Oximeter Instrument C100B - Avoximeter 1000E Cuvettes AVOX1000EL - Whole Blood Oximeter Instrument AVOX1000ERF - Whole Blood Oximeter Instrument AVOX1000ED - Whole Blood Oximeter Instrument E-QCYO - Whole Blood Oximeter Optical QC Filters PDAO - Celite Protamine Dose Assay HRDM3CD - Hemochron Data Manager V3 JEN-QC - Hemochron Electronic System Verification, Normal HE-J04 - Hemochron Electronic System Verification Kit J-1001 - Hemochron Temperature Verification Cartrdige JEA-QC - Hemochron Electronic System Verification, Abnormal GH100 - GEM Hemochron 100 System GH100L - GEM Hemochron 100 System JACT-LR - ACT-LR Cuvettes J201C - Citrate PT Cuvettes SU50I - Surgicutt Bleeding Time Device RQCPRT - RxDx Whole Blood Quality Control Protamine R-PRT400 - Celite Protamine Response Test R-PRT200 - Celite Protamine Response Test 85425 - P2Y12 Test, International 85064 - P2Y12 Test, International 85064-PRO - P2Y12 Test, International JACT+ - ACT+ Cuvettes TF50I - Tenderfoot Newborn Heel Incision Device TFM50I - Tenderfoot Micro-Preemie Heel Incision Device TFP1000I - Tenderfoot Preemie Heel Incision Device TF1000I - Tenderfoot Newborn Heel Incision Device TF200I - Tenderfoot Newborn Heel Incision Device TFT50I - Tenderfoot Toddler Heel Incision Device TFP200I - Tenderfoot Preemie Heel Incision Device TFP50I - Tenderfoot Preemie Heel Incision Device 85310 - IIb/IIIa Test J103 - APTT Cuvettes HRFTK-ACT - Kaolin ACT Tubes HE-ESV - Electronic System Verification Tube HR1003 - Temperature Verification Tube ROTEM Sigma ELITE - Hemochron ELITE Instrument ELITEDEMO - Hemochron ELITE Instrument ELITERF - Hemochron ELITE Instrument RPM-CD - Report Maker V61 ELITEL - Hemochron ELITE Instrument SUP100I - Surgicutt Blotting Paper R-HRT480PK - Kaolin Heparin Response Test PDAOK - Kaolin Protamine Dose Assay R-PRT200K - Kaolin Protamine Response Test R-PRT400K - Kaolin Protamine Response Test DCJLR-N - directCHECK ACT-LR-Normal DCJLR-A - directCHECK ACT-LR-Abnormal DCJACT-A - directCHECK ACT+-Abnormal DCJ-005 - Protective Sleeves DCJACT-N - directCHECK ACT+-Normal Control Test Tube AVOX4000 - Whole Blood CO-Oximeter Instrument AVOX4000RF - Whole Blood CO-Oximeter Instrument 4-TMPB - Whole Blood CO-Oximeter Temperature Probe QV8 - Avoximeter 4000 Cuvettes AVOX4000D - Whole Blood CO-Oximeter Instrument 4-QCYO - Whole Blood CO-Oximeter Optical QC Filters Hemochron Signature Elite DCJPT-N - directCHECK PT-Normal DCJAPTT-N - directCHECK APTT-Normal DCP214-N - HepCheck P214-Normal DCJCAPTT-A - directCHECK Citrate APTT-Abnormal DCJCPT-A - directCHECK Citrate PT-Abnormal DCJCPT-N - directCHECK Citrate PT-Normal DCJAPTT-A - directCHECK APTT-Abnormal DCP214-A - HepCheck P214-Abnormal DCJPT-A - directCHECK PT-Abnormal J103C - Citrate APTT Cuvettes TL100I - Tenderlett Finger Incision Device TL5000I - Tenderlett Finger Incision Device

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Manufacture Medical Device for Another Party (Contract Manufacturer)