Perkinelmer Inc

FDA Filings

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

USANEW YORK STOCK EXCHANGEPKIDUNS 001053610

Perkinelmer Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3007145015
FEI Number3007145015
NamePerkinElmer Health Sciences Inc.
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address17 P&N Drive
Greenville, SC 29611 US
Establishment TypeManufacture Medical Device



Registration Number3009981484
FEI Number3009981484
NamePerkinElmer Inc
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address68 Elm St
Hopkinton, MA 01748 US
Establishment Type
  • Manufacture Medical Device
  • Manufacture Device in the United States for Export Only



Registration Number3004049804
FEI Number3004049804
NameBrian Ciccariello
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address940 Winter St
Waltham, MA 02451 US
Establishment TypeManufacture Medical Device



Registration Number3009194376
FEI Number3009194376
NameBrian Ciccariello
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address940 Winter Street
Waltham, MA 02451 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number3013944243
FEI Number3013944243
NamePerkinElmer Health Sciences Canada, Inc
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address32 Nixon Rd
Bolton Ontario, L7E 1W2 CA
Establishment TypeManufacture Medical Device



Registration Number3006159931
FEI Number3006159931
NamePERKINELMER Health Sciences, Inc.
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address940 WINTER STREET
North Waltham, MA 02451 US
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



Registration Number8043909
FEI Number3002808498
NameBrian Ciccariello
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address940 Winter Street
Waltham, MA 02451 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



Registration Number1224609
FEI Number1000513616
NamePERKINELMER
Owner & OperatorPERKINELMER, INC.
Contact Address940 Winter Street
Waltham MA 02451 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address549 ALBANY ST.
BOSTON, MA 02118 US



FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
ABORh Card2020-03-05
PerkinElmer Inc.
NeoBase 2 Non-derivatized MSMS Kit2020-02-07
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal Creatine Kinase-MM kit (3311-001U)2019-12-20
PerkinElmer Inc.
GSP Neonatal Creatine Kinase - MM Kit2019-12-12
Brian Ciccariello [PERKINELMER, INC.]
GSP? Neonatal Total Galactose kit (3309-002U)2019-11-27
PerkinElmer Inc.
GSP Neonatal Total Galactose Kit2019-11-06
PerkinElmer Inc.
NeoLSD MSMS Kit2019-05-03
Perkinelmer, Inc.
XRpad Digital X-Ray Detector System 95510921H2019-02-21
Perkinelmer, Inc.
XRpad Digital X-Ray Detector System 955109912019-02-21
Perkinelmer, Inc.
XRpad Digital X-Ray Detector System 955109812019-02-21
Perkinelmer, Inc.
XRpad Digital X-Ray Detector System 95510925-022019-02-21
PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]
PerkinElmer GRNK22019-02-21
PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]
PerkinElmer GRNK12019-02-21
Brian Ciccariello [PERKINELMER, INC.]
NeoBase Succinylacetone Assay Solution (3042-0020)2018-11-20
Brian Ciccariello [PERKINELMER, INC.]
NeoBase Non-derivatized MSMS kit (3040-001U)2018-11-20
Brian Ciccariello [PERKINELMER, INC.]
NeoBase Non-derivatized Assay Solutions (3041-0020)2018-11-20
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoBase 2 Succinylacetone Assay Solution (3046-0010)2018-09-12
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoBase 2 Non-derivatized MSMS kit (3044-001U)2018-09-12
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoBase 2 Non-derivatized Assay Solutions (3045-0010)2018-09-12
Brian Ciccariello [PERKINELMER, INC.]
NeoBase 2 Succinylacetone Assay Solution (3046-0010)2018-09-12
Brian Ciccariello [PERKINELMER, INC.]
NeoBase 2 Non-derivatized MSMS kit (3044-001U)2018-09-12
Brian Ciccariello [PERKINELMER, INC.]
NeoBase 2 Non-derivatized Assay Solutions (3045-0010)2018-09-12
PerkinElmer, Inc.
AutoDELFIA hAFP Test Kit2018-09-06
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Brian Ciccariello [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Brian Ciccariello [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Brian Ciccariello [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Brian Ciccariello [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Brian Ciccariello [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Brian Ciccariello [PERKINELMER, INC.]
NeoLSD MSMS kit (3093-001U)2018-07-24
Perkinelmer, Inc.
PerkinElmer 226 2018-07-06
Perkinelmer, Inc.
PerkinElmer 226 2018-07-06
Perkinelmer, Inc.
PerkinElmer 226 2018-07-06
Perkinelmer, Inc.
PerkinElmer 226 2018-07-06
Perkinelmer, Inc.
PerkinElmer 226 2018-07-06
PerkinElmer Health Sciences Canada, Inc [PERKINELMER, INC.]
QSight 225 MD Mass Spectrometer2017-09-06
PerkinElmer Health Sciences Canada, Inc [PERKINELMER, INC.]
QSight 210 MD Mass Spectrometer2017-09-06
PerkinElmer, Inc.
AutoDELFIA hAFP Test System2017-06-07
PerkinElmer, Inc.
PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector2016-09-08
PERKINELMER, INC.
PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector2016-09-01
PerkinElmer, Inc.
AUTODELFIA HAFP TEST SYSTEM2016-08-23
Brian Ciccariello [PERKINELMER, INC.]
GSP Wash Concentrate (4080-0010)2016-08-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Wash Concentrate (PN B117-100, 1244-114, 4010-0010)2016-08-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Inducer (3304-0010)2016-08-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Enhancement Solution (B118-100, 1244-104, 1244-105)2016-08-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Diluent 3 (4021-0010, 4022-0010)2016-08-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Diluent 2 (B131-100, B132-100, B138-100)2016-08-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Diluent 1 (B127-100, B128-100)2016-08-21
PerkinElmer Inc [PERKINELMER, INC.]
LabChip MultiDx instrument2015-03-31
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA Inhibin A kit (B064-112 P1/P2)2015-03-09
Brian Ciccariello [PERKINELMER, INC.]
EnLite Neonatal TREC kit (3401-001U, 3402-001U, 3403-001U)2014-12-16
PerkinElmer, Inc
PerkinElmer, XRpad 4343 F MED Flat Panel Detector2014-10-23
PERKINELMER, INC.
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR2014-08-01
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal Total Galactose Kit (3309-001U)2014-05-19
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal Biotinidase (3307-001U)2013-11-28
PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]
PerkinElmer 226 Sample Collection Device2013-03-14
PerkinElmer Health Sciences Inc. [PERKINELMER, INC.]
Contract Manufactured Collection Device with Ahlstrom 226 filter paper.2013-03-14
PERKINELMER, INC.
PERKINELMER 226 SAMPLE COLLECTION DEVICES2013-03-12
PERKINELMER, INC.
PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR2012-11-28
PerkinElmer, Inc.
AUTODELFIA HAFP TEST SYSTEM2012-06-14
Brian Ciccariello [PERKINELMER, INC.]
chemagic DNA CS200 kit (3207-0010)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
chemagic DNA CS200 kit (3207-0010)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
chemagic 360-D (2024-0010)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
chemagic 360-D (2024-0010)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
Chemagic Prepito Dx (2022-0010)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
Chemagic Prepito Dx (2022-0010)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
Chemagic Prepito D (2022-0020)2012-05-21
Brian Ciccariello [PERKINELMER, INC.]
Chemagic Prepito D (2022-0020)2012-05-21
PerkinElmer, Inc.
AUOTDELFIA HAFP KIT2012-04-27
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA Neonatal IRT kit (B005-204, B005-212)2011-06-27
PerkinElmer, Inc.
AUTODELFIA / DELFIA XPRESS HAFP TEST SYSTEM2011-06-24
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal Thyroxine (T4) kit (3302-001U)2011-04-26
PerkinElmer, Inc.
AUTODELFIA HAFP KIT2011-04-08
Brian Ciccariello [PERKINELMER, INC.]
PinAAcle 900Z (model N3160060)2011-04-05
Brian Ciccariello [PERKINELMER, INC.]
PinAAcle 900T (model N3160082)2011-04-05
Brian Ciccariello [PERKINELMER, INC.]
PinAAcle 900F (model N3160051)2011-04-05
PerkinElmer, Inc.
AUTODELFIA/DELFIA XPRESS HAFP2011-03-04
PerkinElmer, Inc.
AUTODELFIA XPRESS HAFP TEST SYSTEM2011-01-12
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal IRT Kit (3306-001U)2010-12-23
PERKINELMER, INC.
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U2010-08-23
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal 17aOH progesterone kit (3305-001U)2010-07-27
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal GALT Kit (3303-001U)2010-07-16
PERKINELMER, INC.
GSP NEONATALGALT KIT, MODEL 3303-001U2010-06-11
Brian Ciccariello [PERKINELMER, INC.]
Neonatal Biotinidase Kit (3018-0010, 3018-001B)2010-03-11
Brian Ciccariello [PERKINELMER, INC.]
Neonatal Biotinidase Kit (3018-0010, 3018-001B)2010-03-11
Brian Ciccariello [PERKINELMER, INC.]
Neonatal Biotinidase Kit (3018-0010, 3018-001B)2010-03-11
PERKINELMER, INC.
NEONATAL BIOTINIDASE KIT, MODEL 30182010-03-05
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal hTSH kit (3301-001U)2009-09-08
Brian Ciccariello [PERKINELMER, INC.]
GSP Instrument including software (2021-0010)2009-09-08
Brian Ciccariello [PERKINELMER, INC.]
GSP Neonatal hTSH kit (3301-001U)2009-09-08
Brian Ciccariello [PERKINELMER, INC.]
GSP Instrument including software (2021-0010)2009-09-08
PERKINELMER, INC.
GSP INSTRUMENT AND GSP NEONATAL HTSH KIT2009-09-03
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoBase Succinylacetone Assay Solution (3042-0010)2009-07-13
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoBase Non-Derivatized MSMS Kit (3040-001U)2009-07-13
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoBase Non-Derivatized Assay Solutions (3041-0010)2009-07-13
Brian Ciccariello [PERKINELMER, INC.]
NeoBase Succinylacetone Assay Solution (3042-0010)2009-07-13
Brian Ciccariello [PERKINELMER, INC.]
NeoBase Non-Derivatized MSMS Kit (3040-001U)2009-07-13
Brian Ciccariello [PERKINELMER, INC.]
NeoBase Non-Derivatized Assay Solutions (3041-0010)2009-07-13
PERKINELMER, INC.
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 30402009-07-09
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA Neonatal 17 a-OH-progesterone (B024-01C, B024-104, B024-112)2009-04-17
PerkinElmer, Inc.
AUTODELFIA HAFP KIT2009-04-08
Brian Ciccariello [PERKINELMER, INC.]
Neonatal Total Galactose (3029-0010)2008-09-15
Brian Ciccariello [PERKINELMER, INC.]
RESOLVE Hemoglobin kit (FR-9120, FR-9360, FR-9400)2008-04-16
Brian Ciccariello [PERKINELMER, INC.]
JB-2 Staining System (FR-9367)2008-04-16
Brian Ciccariello [PERKINELMER, INC.]
Hb Elution Solution (3024-0010)2008-04-16
Brian Ciccariello [PERKINELMER, INC.]
DELFIA hCG kit (A007-101)2008-02-29
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA hCG kit (B007-101, B007-112)2008-02-29
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Neonatal Thyroxine (T4) kit (A065-110)2008-01-03
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA Neonatal Thyroxine (T4) (B065-112, B065-01C)2008-01-03
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Neonatal hTSH kit (A032-310)2008-01-03
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA Neonatal hTSH kit (B032-02C, B032-312)2008-01-03
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA instrument2007-12-19
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA hAFP kit (B079-212)2007-12-19
Brian Ciccariello [PERKINELMER, INC.]
Neonatal GALT (NG-1100, NG-4100)2007-12-19
Brian Ciccariello [PERKINELMER, INC.]
Neonatal GALT (NG-1100, NG-4100)2007-12-19
Brian Ciccariello [PERKINELMER, INC.]
Neonatal Phenylalanine (NP-1000, NP4000)2007-12-19
Brian Ciccariello [PERKINELMER, INC.]
Neonatal Phenylalanine (NP-1000, NP4000)2007-12-19
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoGram Derivatized Solutions (3030-0010)2007-02-20
PERKINELMER Health Sciences, Inc. [PERKINELMER, INC.]
NeoGram Amino Acids and Acylcarnitines, Tandem Mass Spectrometry kit (3026-0030)2007-02-20
Brian Ciccariello [PERKINELMER, INC.]
NeoGram Derivatized Solutions (3030-0010)2007-02-20
Brian Ciccariello [PERKINELMER, INC.]
NeoGram Amino Acids and Acylcarnitines, Tandem Mass Spectrometry kit (3026-0030)2007-02-20
Brian Ciccariello [PERKINELMER, INC.]
Isoscan System Neonatal Screening (WS-1010)2005-10-27
Brian Ciccariello [PERKINELMER, INC.]
RESOLVE Hemoglobin Testing Equipment (2117-004) no longer sold2005-10-27
Brian Ciccariello [PERKINELMER, INC.]
Migele Gel Electrophoresis Unit (2118-0010)2005-10-27
Brian Ciccariello [PERKINELMER, INC.]
Specimen Gate Laboratory Software2005-04-08
Brian Ciccariello [PERKINELMER, INC.]
PerkinElmer Office Software v3.22005-04-08
Brian Ciccariello [PERKINELMER, INC.]
MSMS Workstation Software (5002-0540)2005-04-08
Brian Ciccariello [PERKINELMER, INC.]
Evoya Software2005-04-08
PerkinElmer Inc [PERKINELMER, INC.]
Panthera-Puncher 9 (TKU) (2081-0010)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
Micromate 196 (TKU)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
LabChip MultiDx 5k reagent kit (HOP)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
LabChip MultiDx 5k chip (HOP)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
LabChip MultiDx 1k reagent kit (HOP)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
LabChip MultiDx 1K chip (HOP)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
DELFIA PlateWash (TKU) (1296-026)2005-02-28
PerkinElmer Inc [PERKINELMER, INC.]
DELFIA Dried Blood Spot Puncher (TKU) (1296-071)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
Panthera-Puncher 9 (TKU) (2081-0010)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
Micromate 196 (TKU)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
LabChip MultiDx 5k reagent kit (HOP)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
LabChip MultiDx 5k chip (HOP)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
LabChip MultiDx 1k reagent kit (HOP)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
LabChip MultiDx 1K chip (HOP)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
DELFIA PlateWash (TKU) (1296-026)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Dried Blood Spot Puncher (TKU) (1296-071)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
DELFIA Plate Shaker2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
TriNEST Microplate incubator and shaker (1296-0050)2005-02-28
Brian Ciccariello [PERKINELMER, INC.]
NCS INCUBATOR2005-02-28
PerkinElmer, Inc.
AUTODELFIA HAFP TEST KIT2002-11-27
PerkinElmer, Inc.
AUTODELFIA HAFP TEST KIT1998-03-31
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA Unconjugated Estriol (uE3) (B095-101U, B095-112)1995-03-30
PerkinElmer Inc [PERKINELMER, INC.]
NGS Express Workstation1993-01-04
PerkinElmer Inc [PERKINELMER, INC.]
JANUS G3 NGS Express Workstation (model CJS4NGS)1993-01-04
PerkinElmer Inc [PERKINELMER, INC.]
JANUS G3 Automated Workstation (models CJS8001, CJSM001)1993-01-04
PerkinElmer Inc [PERKINELMER, INC.]
JANUS G3 Automated Workstation (models CJM4G01, CJM4M01, CJM8001, CJM8G01, CJM8M01, CJMM001, CJMMG01, CJS4001)1993-01-04
PerkinElmer Inc [PERKINELMER, INC.]
JANUS G3 Automated Workstation (models CJL4G01, CJL4M01, CJL8001, CJL8G01, CJL8M01, CJLM001, CJLMG01, CJM4001)1993-01-04
PerkinElmer Inc [PERKINELMER, INC.]
JANUS G3 Automated Workstation (models CJI4001, CJI4G01, CJI4M01, CJI8001, CJI8G01, CJI8M01, CJIM001, CJIMG01, CJL4001)1993-01-04
PerkinElmer Inc [PERKINELMER, INC.]
JANUS Automated Workstation1993-01-04
Brian Ciccariello [PERKINELMER, INC.]
Wizard1993-01-04
Brian Ciccariello [PERKINELMER, INC.]
Wizard21993-01-04
Brian Ciccariello [PERKINELMER, INC.]
Victor D (1420-020, 1420-021)1992-05-21
Brian Ciccariello [PERKINELMER, INC.]
VICTOR EnLite instrument with EnLite Workstation Software (1420-0220, 1420-0230)1992-05-21
Brian Ciccariello [PERKINELMER, INC.]
AutoDELFIA instrument (models 1297-014, 1235-014, 1235-501, 1235-714, 1297-0110, 1235-0110, 1235-5110, 1235-5220)1992-05-21
Brian Ciccariello [PERKINELMER, INC.]
DELFIA hLH Spec (A031-101)1992-05-21

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