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ARK DIAGNOSTICS INC

Matched from indexed company URL: ARK Diagnostics, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057552443005755244ARK DIAGNOSTICS INC1N2026-01-0148089 Fremont Blvd Fremont CA US 94538

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812101031230ARK™ Apixaban Assay - The ARK™ Apixaban Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of apixaban in 3.2% citrated human plasma on automated clinical chemistry analyzers. Apixaban concentrations can be used as an aid in management of patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: patients at risk for major bleeding, patient experiencing a bleeding episode. The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. For use in adult population.5102706270customersupport@ark-tdm.com
00812101031247ARK™ Apixaban Calibrator - The ARK™ Apixaban Calibrator is intended for use in calibration of the ARK Apixaban Assay.5102706270customersupport@ark-tdm.com
00812101031254ARK™ Apixaban Control - The ARK™ Apixaban Control is an assayed quality control material intended for use in quality control of the ARK Apixaban Assay.5102706270customersupport@ark-tdm.com
00812101031599ARK™ Ketamine II Assay - The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.5102706270customersupport@ark-tdm.com
00812101031605ARK™ Ketamine II Assay - The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.5102706270customersupport@ark-tdm.com
00812101031612ARK™ Ketamine II Assay - The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.5102706270customersupport@ark-tdm.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
959951627689118K232522ARK Levetiracetam II AssayORI2024-02-27
959951480435104K232017ARK Methotrexate II AssayLAO2023-12-20
959951706414982K231752ARK Hydrocodone AssayDJG2023-11-09
959951308453116K201089ARK Lacosamide AssayNWM2021-08-05
959951376352262K200197ARK Fentanyl II AssayDJG2020-02-26
959951684484016K182779ARK EDDP AssayDJR2018-11-21
959951357383437K182280ARK Tramadol AssayDJG2018-12-10
959951508381253K180427ARK Fentanyl AssayDJG2018-06-06
959951855655044K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite ControlPOX2016-08-09
959951454645027K111904ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RANLAO2011-10-18
959951594724337K101574ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0OTF2010-11-23
959951545984549K101305ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROLORH2010-10-29
959951021516410K091884ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003NWM2009-12-09
959951396407832K091653ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00ORI2009-11-02
959951967475494K083799TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00NWM2009-04-16
959951107436605DEN160033ARK Voriconazole II Assay Test SystemPUJ2017-05-05
959951009768869
959951045653042
959951217158091
959951219062624
959951245061582
959951283574575
959951334917932
959951358317008
959951436153089
959951537138786
959951601761784
959951696333212
959952023335067

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DJG42023-11-09
NWM32021-08-05
ORI22024-02-27
LAO22023-12-20
DJR12018-11-21
PUJ12017-05-05
POX12016-08-09
OTF12010-11-23
ORH12010-10-29

PMN#

GUDID#

172 records. Showing 1-40. Next