Ark Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Ark 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 Number3005755244
FEI Number3005755244
NameARK DIAGNOSTICS INC
Owner & OperatorARK Diagnostics Inc
Contact Address48089 Fremont Blvd
Fremont CA 94538 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address48089 Fremont Blvd
Fremont, CA 94538 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



FDA Filings

Device
Company
DeviceDate
ARK DIAGNOSTICS INC
DRI Tramadol Control Kit B400003542024-11-22
ARK DIAGNOSTICS INC
DRI Tramadol Calibrator Kit B400003662024-11-22
ARK DIAGNOSTICS INC
DRI Tramadol Cutoff Calibrator Kit B400003522024-11-22
ARK DIAGNOSTICS INC
DRI Tramadol Negative Calibrator Kit B400003532024-11-22
ARK DIAGNOSTICS INC
DRI Tramadol Assay - 115mL B400003512024-11-22
ARK DIAGNOSTICS INC
DRI Tramadol Assay - 500 mL B400003502024-11-22
ARK DIAGNOSTICS INC
ARK Levetiracetam II Assay 5070-0001-012024-11-04
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Dilution Buffer 5071-0004-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Control 5071-0003-022024-11-01
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Control 5071-0003-012024-11-01
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Control 5071-0003-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Calibrator 5071-0002-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Assay 5071-0001-012024-11-01
ARK DIAGNOSTICS INC
ARK™ Methotrexate II Assay 5071-0001-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Levetiracetam II Control 5070-0003-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Levetiracetam II Calibrator 5070-0002-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Levetiracetam II Assay 5070-0001-002024-11-01
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Control 5076-0003-002024-10-24
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Calibrator Cutoff 5076-0002-022024-10-24
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Calibrator Negative 5076-0002-012024-10-24
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Calibrator 5076-0002-002024-10-24
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Assay 5076-0001-022024-10-24
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Assay 5076-0001-012024-10-24
ARK DIAGNOSTICS INC
ARK™ Hydrocodone Assay 5076-0001-002024-10-24
ARK DIAGNOSTICS INC
ARK™ Pregabalin II Assay 5059-0001-012024-01-01
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II 150/250ng/mL Control 5073-0003-012021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II 75/125ng/mL Control 5073-0003-002021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II 200ng/mL Cutoff Calibrator 5073-0002-032021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II 100ng/mL Cutoff Calibrator 5073-0002-022021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II Negative Calibrator 5073-0002-012021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II Calibrator 5073-0002-002021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II Assay 5073-0001-022021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II Assay 5073-0001-012021-09-08
ARK DIAGNOSTICS INC
ARK™ HS Benzodiazepine II Assay 5073-0001-002021-09-08
ARK Diagnostics, Inc.
ARK Lacosamide Assay2021-08-05
ARK DIAGNOSTICS INC
DRI™ Fentanyl II Control 100288752021-06-04
ARK DIAGNOSTICS INC
DRI™ Fentanyl II Cutoff Calibrator 100288732021-06-04
ARK DIAGNOSTICS INC
DRI™ Fentanyl II Negative Calibrator 100288742021-06-04
ARK DIAGNOSTICS INC
DRI™ Fentanyl II Assay - 500mL 100288712021-06-04
ARK DIAGNOSTICS INC
DRI™ Fentanyl II Assay 100288722021-06-04
ARK DIAGNOSTICS INC
ARK™ Methotrexate Assay 5026-0001-032020-09-08
ARK DIAGNOSTICS INC
ARK™ Fentanyl II Assay - 500mL (WPT) 5072-0001-002020-07-16
ARK DIAGNOSTICS INC
ARK? Fentanyl II Assay; ARK? Fentanyl Calibrator; ARK? Fentanyl Control2020-03-17
ARK DIAGNOSTICS INC
ARK™ Fentanyl II Assay - 500mL 5069-0001-022020-03-06
ARK DIAGNOSTICS INC
ARK™ Fentanyl II Assay 5069-0001-012020-03-06
ARK DIAGNOSTICS INC
ARK™ Fentanyl II Assay 5069-0001-002020-03-06
ARK Diagnostics, Inc.
ARK™ Fentanyl II Assay2020-02-26
ARK DIAGNOSTICS INC
ARK™ Levetiracetam Control 5024-0003-002020-01-09
ARK DIAGNOSTICS INC
ARK™ Levetiracetam Calibrator 5024-0002-002020-01-09
ARK DIAGNOSTICS INC
ARK™ Levetiracetam Assay 5024-0001-002020-01-09
ARK DIAGNOSTICS INC
ARK™ AB-PINACA Control 5055-0003-002019-07-31
ARK DIAGNOSTICS INC
ARK™ AB-PINACA Cutoff Calibrator 5055-0002-022019-07-31
ARK DIAGNOSTICS INC
ARK™ AB-PINACA Negative Calibrator 5055-0002-012019-07-31
ARK DIAGNOSTICS INC
ARK™ AB-PINACA Assay 5055-0001-012019-07-31
ARK DIAGNOSTICS INC
ARK™ AB-PINACA Assay 5055-0001-002019-07-31
ARK DIAGNOSTICS INC
ARK™ UR-144/JWH-018 Control 5054-0003-002019-07-31
ARK DIAGNOSTICS INC
ARK™ UR-144/JWH-018 Cutoff Calibrator 5054-0002-022019-07-31
ARK DIAGNOSTICS INC
ARK™ UR-144/JWH-018 Negative Calibrator 5054-0002-012019-07-31
ARK DIAGNOSTICS INC
ARK™ UR-144/JWH-018 Assay 5054-0001-012019-07-31
ARK DIAGNOSTICS INC
ARK™ UR-144/JWH-018 Assay 5054-0001-002019-07-31
ARK DIAGNOSTICS INC
ARK™ Ketamine Control 5056-0003-002019-07-31
ARK DIAGNOSTICS INC
ARK™ Ketamine Cutoff Calibrator 5056-0002-022019-07-31
ARK DIAGNOSTICS INC
ARK™ Ketamine Negative Calibrator 5056-0002-012019-07-31
ARK DIAGNOSTICS INC
ARK™ Ketamine Calibrator 5056-0002-002019-07-31
ARK DIAGNOSTICS INC
ARK™ Ketamine Assay (115mL) 5056-0001-012019-07-31
ARK DIAGNOSTICS INC
ARK™ Ketamine Assay 5056-0001-002019-07-31
ARK DIAGNOSTICS INC
ARK™ Meperidine Control 5039-0003-002019-07-30
ARK DIAGNOSTICS INC
ARK™ Meperidine Cutoff Calibrator 5039-0002-022019-07-30
ARK DIAGNOSTICS INC
ARK™ Meperidine Negative Calibrator 5039-0002-012019-07-30
ARK DIAGNOSTICS INC
ARK™ Meperidine Calibrator 5039-0002-002019-07-30
ARK DIAGNOSTICS INC
ARK™ Meperidine Assay 5039-0001-012019-07-30
ARK DIAGNOSTICS INC
ARK™ Meperidine Assay 5039-0001-002019-07-30
ARK DIAGNOSTICS INC
ARK™ Pregabalin II Control 5059-0003-002019-07-11
ARK DIAGNOSTICS INC
ARK™ Pregabalin II Calibrator 5059-0002-002019-07-11
ARK DIAGNOSTICS INC
ARK™ Pregabalin II Assay 5059-0001-002019-07-11
ARK DIAGNOSTICS INC
ARK? UR-144/JWH-018 Control2019-06-17
ARK DIAGNOSTICS INC
ARK? UR-144/JWH-018 Calibrator2019-06-17
ARK DIAGNOSTICS INC
ARK? UR-144/JWH-018 Assay2019-06-17
ARK DIAGNOSTICS INC
ARK? AB-PINACA Control2019-06-17
ARK DIAGNOSTICS INC
ARK? AB-PINACA Calibrator2019-06-17
ARK DIAGNOSTICS INC
ARK? AB-PINACA Assay2019-06-17
ARK DIAGNOSTICS INC
ARK? Ketamine Control2019-06-17
ARK DIAGNOSTICS INC
ARK? Ketamine Calibrator2019-06-17
ARK DIAGNOSTICS INC
ARK? Ketamine Assay2019-06-17
ARK DIAGNOSTICS INC
ARK™ EDDP Control (225/375) 5051-0003-012019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP Control (75/125) 5051-0003-002019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP 300 Cutoff Calibrator 5051-0002-032019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP 100 Cutoff Calibrator 5051-0002-022019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP Negative Calibrator 5051-0002-012019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP Calibrator 5051-0002-002019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP Assay - 500mL 5051-0001-022019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP Assay - 115mL 5051-0001-012019-02-21
ARK DIAGNOSTICS INC
ARK™ EDDP Assay 5051-0001-002019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Control 5040-0003-002019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Cutoff Calibrator 5040-0002-022019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Negative Calibrator 5040-0002-012019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Calibrator 5040-0002-002019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Assay (500mL) 5040-0001-022019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Assay (115mL) 5040-0001-012019-02-21
ARK DIAGNOSTICS INC
ARK™ Tramadol Assay 5040-0001-002019-02-21
ARK DIAGNOSTICS INC
ARK? EDDP Control2019-01-16
ARK DIAGNOSTICS INC
ARK? EDDP Calibrator2019-01-16
ARK DIAGNOSTICS INC
ARK? EDDP Assay2019-01-16
ARK DIAGNOSTICS INC
ARK? Tramadol Control2019-01-16
ARK DIAGNOSTICS INC
ARK? Tramadol Calibrator2019-01-16
ARK DIAGNOSTICS INC
ARK? Tramadol Assay2019-01-16
ARK Diagnostics, Inc.
ARK Tramadol Assay2018-12-10
ARK Diagnostics, Inc.
ARK EDDP Assay2018-11-21
ARK DIAGNOSTICS INC
ARK™ Methylphenidate Metabolite Assay 5042-0001-002018-11-01
ARK DIAGNOSTICS INC
ARK™ Methylphenidate Metabolite Cutoff Calibrator 5042-0002-022018-10-30
ARK DIAGNOSTICS INC
ARK™ Methylphenidate Negative Calibrator 5042-0002-012018-10-30
ARK DIAGNOSTICS INC
ARK™ Methylphenidate Metabolite Control 5042-0003-002018-10-30
ARK DIAGNOSTICS INC
ARK™ Methylphenidate Metabolite Calibrator 5042-0002-002018-10-30
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Control (750/1250) 5036-0006-012018-10-15
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Control (375/625) 5036-0006-002018-10-15
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Negative Calibrator 5036-0005-012018-08-13
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Calibrator 5036-0005-002018-08-13
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Assay 5036-0004-022018-08-13
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Assay 5036-0004-012018-08-13
ARK DIAGNOSTICS INC
ARK™ Ethyl Glucuronide Assay 5036-0004-002018-08-13
ARK DIAGNOSTICS INC
ARK? Fentanyl Control2018-06-11
ARK DIAGNOSTICS INC
ARK? Fentanyl Calibrator2018-06-11
ARK DIAGNOSTICS INC
ARK? Fentanyl Assay2018-06-11
ARK Diagnostics, Inc.
ARK Fentanyl Assay2018-06-06
ARK DIAGNOSTICS INC
ARK Methylphenidate Metabolite Control2018-06-01
ARK DIAGNOSTICS INC
ARK Methylphenidate Metabolite Calibrator2018-06-01
ARK DIAGNOSTICS INC
ARK Methylphenidate Metabolite Assay2018-06-01
ARK DIAGNOSTICS INC
ARK Linezolid Control2018-05-23
ARK DIAGNOSTICS INC
ARK Linezolid Calibrator2018-05-23
ARK DIAGNOSTICS INC
ARK Linezolid Assay2018-05-23
ARK DIAGNOSTICS INC
ARK Fentanyl 0.5 ng/mL Assay/Calibrator/Control2018-04-11
ARK DIAGNOSTICS INC
ARK? Ethyl Glucuronide Control2017-11-21
ARK DIAGNOSTICS INC
ARK? Ethyl Glucuronide Calibrator2017-11-21
ARK DIAGNOSTICS INC
ARK? Ethyl Glucuronide Assay2017-11-21
ARK Diagnostics, Inc.
ARK Methotrexate Assay2017-08-18
ARK DIAGNOSTICS INC
ARK Voriconazole II Control2017-05-09
ARK DIAGNOSTICS INC
ARK Voriconazole II Calibrator2017-05-09
ARK DIAGNOSTICS INC
ARK Voriconazole II Assay2017-05-09
ARK DIAGNOSTICS INC
ARK? Meperidine Control2017-05-09
ARK DIAGNOSTICS INC
ARK? Meperidine Calibrator2017-05-09
ARK DIAGNOSTICS INC
ARK? Meperidine Assay2017-05-09
ARK DIAGNOSTICS, INC
ARK Voriconazole II Assay Test System2017-05-05
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Control2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Calibrator2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Assay2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Control2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Calibrator2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Assay2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Control2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Calibrator2016-08-18
ARK DIAGNOSTICS INC
ARK Oxcarbazepine Metabolite Assay2016-08-18
ARK DIAGNOSTICS, INC.
ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control2016-08-09
ARK DIAGNOSTICS INC
ARK Pregabalin Urine Control2015-06-26
ARK DIAGNOSTICS INC
ARK Pregabalin Urine Calibrator2015-06-26
ARK DIAGNOSTICS INC
ARK Pregabalin Urine Assay2015-06-26
ARK DIAGNOSTICS INC
ARK Pregabalin II Control2015-06-26
ARK DIAGNOSTICS INC
ARK Pregabalin II Calibrator2015-06-26
ARK DIAGNOSTICS INC
ARK Pregabalin II Assay2015-06-26
ARK DIAGNOSTICS INC
ARK Lacosamide Control2015-06-26
ARK DIAGNOSTICS INC
ARK Lacosamide Calibrator2015-06-26
ARK DIAGNOSTICS INC
ARK Lacosamide Assay2015-06-26
ARK DIAGNOSTICS INC
ARK Efavirenz Control2014-08-26
ARK DIAGNOSTICS INC
ARK Efavirenz Calibrator2014-08-26
ARK DIAGNOSTICS INC
ARK Efavirenz Assay2014-08-26
ARK DIAGNOSTICS INC
ARK Methotrexate Dilution Buffer2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Control2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Calibrator2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Assay2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Dilution Buffer2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Control2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Calibrator2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Assay2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Dilution Buffer2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Control2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Calibrator2011-10-25
ARK DIAGNOSTICS INC
ARK Methotrexate Assay2011-10-25
ARK DIAGNOSTICS,INC
ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN2011-10-18
ARK DIAGNOSTICS INC
ARK Gabapentin Control2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Calibrator2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Assay2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Control2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Calibrator2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Assay2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Control2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Calibrator2010-11-30
ARK DIAGNOSTICS INC
ARK Gabapentin Assay2010-11-30
ARK DIAGNOSTICS,INC
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-02010-11-23
ARK DIAGNOSTICS INC
ARK Lamotrigine Control2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Calibrator2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Assay2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Control2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Calibrator2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Assay2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Control2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Calibrator2010-11-05
ARK DIAGNOSTICS INC
ARK Lamotrigine Assay2010-11-05
ARK DIAGNOSTICS,INC
ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL2010-10-29
ARK DIAGNOSTICS INC
ARK Zonisamide Control2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Calibrator2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Assay2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Control2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Calibrator2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Assay2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Control2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Calibrator2009-12-22
ARK DIAGNOSTICS INC
ARK Zonisamide Assay2009-12-22
ARK DIAGNOSTICS,INC
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-00032009-12-09
ARK DIAGNOSTICS INC
ARK Levetiracetam Control2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Calibrator2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Assay2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Control2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Calibrator2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Assay2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Control2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Calibrator2009-11-19
ARK DIAGNOSTICS INC
ARK Levetiracetam Assay2009-11-19
ARK DIAGNOSTICS,INC
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-002009-11-02
ARK DIAGNOSTICS INC
ARK Topiramate Control2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Calibrator2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Assay2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Control2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Calibrator2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Assay2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Control2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Calibrator2009-04-30
ARK DIAGNOSTICS INC
ARK Topiramate Assay2009-04-30
ARK DIAGNOSTICS,INC
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-002009-04-16

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