Accriva Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Accriva Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3002721930
FEI Number2250033
NameAccriva Diagnostics, Inc.
Owner & OperatorAccriva Diagnostics Inc.
Contact Address6260 Sequence Drive
San Diego CA 92121 US
Official Correspondent
  • Paula Morgan
  • 001-858-2632590-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address6260 Sequence Dr
San Diego, CA 92121 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
Accriva Diagnostics, Inc.
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), DirectCHECK ACT+ Whole Blood Control, Level 1 And Level 2, DirectCHECK ACT-LR Whole Blood Control2021-12-29
Accriva Diagnostics, Inc.
Hemochron Signature Elite2019-11-22
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
ROTEM Sigma2019-10-28
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
P214 - ACT Tubes2016-07-06
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRFTCA510 - Celite ACT Tubes2016-07-06
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85225 - PRUTest2015-11-20
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85066 - VerifyNow System, International2015-02-27
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85065 - VerifyNow System, International2015-02-27
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJLR-N - directCHECK ACT-LR-Normal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJLR-A - directCHECK ACT-LR-Abnormal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJACT-N - directCHECK ACT+-Normal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJACT-A - directCHECK ACT+-Abnormal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJ-005 - Protective Sleeves2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260060600 - GEM Check Coag ACT-Normal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260060600 - GEM Check Coag ACT-LR-Normal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260060300 - GEM Check Coag ACT-Abnormal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260060200 - GEM Check Coag ACT-LR-Abnormal2014-12-16
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
SUP100I - Surgicutt Blotting Paper2014-12-11
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86003L - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86003D - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86003 - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86000RF - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86000L - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86000D - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
86000 - VerifyNow Instrument2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85063 - Validation Kit2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85062 - Preventative Maintenance Kit2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85047 - WQC2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
70068 - EQC2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85425 - P2Y12 Test, International2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85064-PRO - P2Y12 Test, International2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85064 - P2Y12 Test, International2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85053-10 - Aspirin Test2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85053 - Aspirin Test2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85310 - IIb/IIIa Test2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
85047 - WQC2014-12-09
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HR1003 - Temperature Verification Tube2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HE-ESV - Electronic System Verification Tube2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.RF - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.110L - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.110D - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.110 - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.RF - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.110L - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.110D - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRS.110 - Hemochron Response Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
J201C - Citrate PT Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260032000 - Citrate PT GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
J103C - Citrate APTT Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260036000 - Citrate APTT GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
J103C - Citrate APTT Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260036000 - Citrate APTT GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
JACT-LR - ACT-LR Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260040000 - ACT-LR GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
QV8 - Avoximeter 4000 Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOXD4000L - Whole Blood CO-Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX4000RF - Whole Blood CO-Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX4000D - Whole Blood CO-Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX4000 - Whole Blood CO-Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6320480221 - GEM OPL Optical QC Filters2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6320480210 - GEM OPL Temperature Probe2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6320480100 - GEM OPL Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6320480000 - GEM OPL Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
4-TMPB - Whole Blood CO-Oximeter Temperature Probe2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
4-QCYO - Whole Blood CO-Oximeter Optical QC Filters2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCP214-N - HepCheck P214-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCP214-A - HepCheck P214-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJPT-N - directCHECK PT-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJPT-A - directCHECK PT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJCPT-N - directCHECK Citrate PT-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJCPT-A - directCHECK Citrate PT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJCAPTT-A - directCHECK Citrate APTT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJAPTT-N - directCHECK APTT-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
DCJAPTT-A - directCHECK APTT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260061700 - GEM CHECK Coag PT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260061600 - GEM CHECK Coag APTT-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260061400 - GEM CHECK Coag Cit PT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260061100 - GEM CHECK Coag Cit PT-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260060400 - GEM CHECK Coag PT-Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260060100 - GEM CHECK Coag APTT-Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
JACT+ - ACT+ Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260038000 - ACT GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
J201 - PT Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260030000 - PT GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
J103 - APTT Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260034000 - APTT GEM Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TL5000I - Tenderlett Finger Incision Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TL100I - Tenderlett Finger Incision Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
E-QCYO - Whole Blood Oximeter Optical QC Filters2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
C100B - Avoximeter 1000E Cuvettes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX1000ERF - Whole Blood Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX1000EL - Whole Blood Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX1000ED - Whole Blood Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
AVOX1000E - Whole Blood Oximeter Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRFTK-ACT - Kaolin ACT Tubes2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TFT50I - Tenderfoot Toddler Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TFP50I - Tenderfoot Preemie Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TFP200I - Tenderfoot Preemie Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TFP1000I - Tenderfoot Preemie Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TFM50I - Tenderfoot Micro-Preemie Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
RQCPRT - RxDx Whole Blood Quality Control Protamine2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
R-PRT400 - Celite Protamine Response Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
R-PRT200 - Celite Protamine Response Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
RQCHRT - RxDx Whole Blood Quality Control Heparin2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
R-HRT480P - Heparin Response Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TF50I - Tenderfoot Newborn Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TF200I - Tenderfoot Newborn Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
TF1000I - Tenderfoot Newborn Heel Stick Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
Control Test Tube2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
PDAO - Celite Protamine Dose Assay2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
SU50I - Surgicutt Bleeding Time Device2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
RPM-CD - Report Maker V6.012014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
ELITERF - Hemochron ELITE Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
ELITEL - Hemochron ELITE Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
ELITEDEMO - Hemochron ELITE Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
ELITE - Hemochron ELITE Instrument2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
RxDx - Hemochron Response Analysis Module2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
JEN-QC - Hemochron Electronic System Verification, Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
JEA-QC - Hemochron Electronic System Verification, Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
J-1001 - Hemochron Temperature Verification Cartrdige2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HRDM3CD - Hemochron Data Manager V3.02014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
HE-J04 - Hemochron Electronic System Verification Kit2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260020000 - GEM PCL Electronic System Verification Kit2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260019000 - GEM PCL Temperature Verification Cartrdige2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260018000 - GEM PCL Electronic System Verification, Abnormal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260017000 - GEM PCL Electronic System Verification, Normal2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
6260011500 - GEM PCL System2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
R-PRT400K - Kaolin Protamine Response Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
R-PRT200K - Kaolin Protamine Response Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
R-HRT480PK - Kaolin Heparin Response Test2014-12-01
Accriva Diagnostics, Inc. [Accriva Diagnostics Inc.]
PDAOK - Kaolin Protamine Dose Assay2014-12-01

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020091480590Yantian,China (Mainland) -> Long Beach, California12001-B MAINBODY HS CODE:3926909090 431CTNS ON 13PLTS431 CTN
2020071736563Yantian,China (Mainland) -> Long Beach, California12001 MAINBODY 12002-A LEFTCOVER W VLOVES493 CTN
2020062241926Yantian,China (Mainland) -> Los Angeles, California12001-B MAINBODY 12002-A LEFTCOVER W VALVES REV A 12007 LEFTCOVER W O VALVES (526CTNS PACKED ON 10PLTS AND 18 LOOSE CTNS)526 CTN
2020051925758Yantian,China (Mainland) -> Los Angeles, California12001 MAINBODY 12002-A LEFTCOVER W VLOVES 12003-A RIGHT COVER461 CTN

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