Hemagen Diagnostics Inc

FDA Filings

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

USAOTHER OTC MarketHMGNDUNS 147827216
FDA Registration(s)
Registration Number1181055
FEI Number1181055
NameHEMAGEN DIAGNOSTICS, INC.
Owner & OperatorHEMAGEN DIAGNOSTICS, INC.
Contact Address9033 RED BRANCH RD. --
Columbia MD 21045 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9033 RED BRANCH RD.
COLUMBIA, MD 21045 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Hemagen Diagnostics, Inc.
Cytomegalovirus / CMV IgM IFA 96 Test 2023-10-16
Hemagen Diagnostics, Inc.
Cytomegalovirus / CMV IgG IFA 96 Test 2023-10-16
Hemagen Diagnostics, Inc.
Mumps IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Mumps IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Measles IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Measles IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Chlamydia trachomatis / C. trach IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Varicella-Zoster Virus / VZV IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Rubella IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Rubella IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Anti-nDNA IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
ANA/HEp-2 IgG IFA 120 Test 2023-10-13
Hemagen Diagnostics, Inc.
ANA/HEp-2 IgG IFA 1200 Test 2023-10-13
Hemagen Diagnostics, Inc.
ANA/HEp-2 IgG IFA 600 Test 2023-10-13
Hemagen Diagnostics, Inc.
ANA/HEp-2 IgG IFA 180 Test 2023-10-13
Hemagen Diagnostics, Inc.
ANA/HEp-2 IgG IFA 96 Test 2023-10-13
Hemagen Diagnostics, Inc.
Toxo IgG IFA Slide Only Kit 2023-10-13
Hemagen Diagnostics, Inc.
Toxo IgG IFA 204 Test 2023-10-13
Hemagen Diagnostics, Inc.
Toxo IgG IFA 120 Test 2023-10-13
HEMAGEN DIAGNOSTICS, INC.
Beta 2 Glycoprotein IgM Elisa Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Beta 2 Glycoprotein IgA Elisa Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Beta 2 Glycoprotein IgG Elisa Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Anti Mitochondrial Antibody Indirect Immunofluorescent Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Rheumatoid Factor Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Antinuclear Antibody, Indirect Immunofluorescent nDNA kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
C-Reactive Protein Elisa Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, SmRNP2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (EIA) Screening Kit, Jo-12016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, Sm2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, Scl-70 Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, SS-A2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, SS-B2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Cytomegalovirus Elisa Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
C-Reactive Protein Elisa Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (EIA) Screening Kit, Jo-12016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (EIA) Screening Kit, Scl-702016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, SmRNP2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit, SS-A2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Extractable Antinuclear Antibody (ENA) Screening Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Thyroxine (T4) Rotor2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Theophylline Calibrator2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Analytical Thyroid Rotor2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Analytical Rotor (T4) Thyroxine & Thyroxine Uptake Calibrator2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Theophylline Rotor2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Test Rotors Cresolphthalein complexone, calcium2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Analyst Benchtop Clinical Chemistry Analyzer2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Respiratory Syncytial Virus (RSV) Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Mumps Virus Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Measles (Rubeola) Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Calibrator Standard2016-11-06
HEMAGEN DIAGNOSTICS, INC.
Phosphorus Reagent2016-11-06
HEMAGEN DIAGNOSTICS, INC.
CMV PK System Controls2016-11-06
HEMAGEN DIAGNOSTICS, INC.
CMV PK System 2000 Test Kit2016-11-06
HEMAGEN DIAGNOSTICS, INC.
VZV IgG IFA2011-10-20
HEMAGEN DIAGNOSTICS, INC.
Virgo MPO (P Anca) Antibody Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen MPO (P Anca) Antibody Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Pr3 (C Anca) Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen PR3 (C Anca) Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo anti-neutrophil cytoplasmic antibodies (ANCA) Screen Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen anti-neutrophil cytoplasmic antibodies (ANCA) Screen Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Anti-Cardiolipin IgA IgG IgM Screen Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Anti-Cardiolipin IgA IgG IgM Screen Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Anti-Cardiolipin IgA Antibody Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Anti-Cardiolipin IgA Antibody Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Anti-Cardiolipin Antibody IgG IgM Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Anti-Cardiolipin Antibody IgG IgM Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Chagas EIA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ENA Screening Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ENA Screening Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ENA Screening Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ENA Screening Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ENA Jo 1 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ENA Jo 1 Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ENA Jo 1 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ENA Jo 1 Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Analyst Analytical Test Rotor (Chem 14)2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Dupont Analyst Analytical Test Rotor (Chem 14)2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Analyst Analytical Test Rotor (Chem 14)2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ENA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ENA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Scl - 70 EIA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Scl - 70 EIA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Lipid Rotor2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo SS-A/SS-B Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo SS-A/SS-B Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen SS-A/SS-B Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen SS-A/SS-B Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Analyst Multi Analyste Serum Control2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo RF Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo RF Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen RF Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen RF Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo RNP/sm Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo RNP/sm Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen RNP/sm Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen RNP/sm Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ds DNA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ds DNA Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ds DNA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ds DNA Kit HA2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ANA HEp-2 Kit, IFA Method2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo c.trach Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Chlamydia Trachomatis IFA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen c.trach IFA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Chlamydia Trachomatis IFA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Epstein-Barr Virus Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Epstein-Barr Virus Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Rubella Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Rubella Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Herpes Simplex Virus (HSV) 1&2 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Herpes Simplex Virus (HSV) 1&2 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Herpes Simplex Virus (HSV) 1 & 2 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo ANA HEp-2 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen ANA HEp-2 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
ANA HEp-2 Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Panels Plus2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Panels Plus2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Panels Plus2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Panels Plus2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Cytomegalovirus (CMV) IgM Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Cytomegalovirus (CMV) IgM Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo FTA ABS IFA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen FTA ABS IFA Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Toxoplasma (Toxo) Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Toxoplasma (Toxo) Kit2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Virgo Antimitochondrial (AMA) KIt2009-12-02
HEMAGEN DIAGNOSTICS, INC.
Hemagen Antimitochondrial (AMA) KIt2009-12-02
HEMAGEN DIAGNOSTICS, INC.
IgM universal Conjugate2009-05-07
HEMAGEN DIAGNOSTICS, INC.
RAICHEM GLUCOSE UV (LIQUID)2004-06-30
HEMAGEN DIAGNOSTICS, INC.
RAICHEM CALCIUM (OCPC) LIQUID REAGENT2004-06-25
HEMAGEN DIAGNOSTICS, INC.
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 22003-06-16
HEMAGEN DIAGNOSTICS, INC.
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER2002-12-24
HEMAGEN DIAGNOSTICS, INC.
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT2002-09-17
HEMAGEN DIAGNOSTICS, INC.
RAICHEM LIPID CALIBRATOR2002-09-03
HEMAGEN DIAGNOSTICS, INC.
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM2002-07-29
HEMAGEN DIAGNOSTICS, INC.
MODIFICATION TO RAICHEM CALCIUM REAGENT2002-07-19
HEMAGEN DIAGNOSTICS, INC.
RAICHEM GLUCOSE UV REAGENT2001-10-15
HEMAGEN DIAGNOSTICS, INC.
RAICHEM BUN RATE REAGENT2001-10-15
HEMAGEN DIAGNOSTICS, INC.
ANALYST PANELS + ANALYTICAL TEST ROTOR2001-05-21
HEMAGEN DIAGNOSTICS, INC.
RAICHEM CREATININE URINE STANDARD2001-05-02
HEMAGEN DIAGNOSTICS, INC.
RAICHEM PHOSPORUS REAGENT2000-10-25
HEMAGEN DIAGNOSTICS, INC.
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT1999-08-30
HEMAGEN DIAGNOSTICS, INC.
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT1999-08-30
HEMAGEN DIAGNOSTICS, INC.
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT1999-08-30
HEMAGEN DIAGNOSTICS, INC.
Lipid1998-09-08
HEMAGEN DIAGNOSTICS, INC.
VIRGO PANCO KIT1997-11-13
HEMAGEN DIAGNOSTICS, INC.
PR 3 ANTIBODY KIT1997-11-13
HEMAGEN DIAGNOSTICS, INC.
VIRGO ANCA SCREEN KIT1997-11-13
HEMAGEN DIAGNOSTICS, INC.
RAICHEM PREALBUMIN SPIA1997-08-28
HEMAGEN DIAGNOSTICS, INC.
VIRGO AMA ELISA KIT1997-06-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ANTI CARDIOLIPIN SCREEN1997-06-03
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN CMV IGG KIT1997-02-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA DSDNA KIT (EIA METHOD)1996-12-05
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)1996-09-12
Hemagen Diagnostics, Inc.
Test, Donor, CMV1996-07-15
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN CRP 150 KIT (EIA METHOD)1996-03-12
HEMAGEN DIAGNOSTICS, INC.
Virgo Respiratory Syncytial Virus(RSV) Kit1995-07-11
HEMAGEN DIAGNOSTICS, INC.
Respiratory Syncytial Virus(RSV) Kit1995-07-11
HEMAGEN DIAGNOSTICS, INC.
Hemagen Respiratory Syncytial Virus(RSV) Kit1995-07-11
HEMAGEN DIAGNOSTICS, INC.
Virgo Measles (Rubeola) Kit1995-07-11
HEMAGEN DIAGNOSTICS, INC.
Hemagen Measles (Rubeola) Kit1995-07-11
HEMAGEN DIAGNOSTICS, INC.
Virgo Mumps Kit IFA Method1995-07-11
HEMAGEN DIAGNOSTICS, INC.
Hemagen Mumps KIt IFA Method1995-07-11
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)1995-06-05
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREENING KIT (EIA METHOD)1995-06-05
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN CHAGAS' KIT (EIA METHOD)1995-05-19
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SM/RMP KIT (EIA METHOD)1995-03-29
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA JO-1 KIT (EIA METHOD)1995-02-22
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SM KIT (EIA METHOD)1995-02-22
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCL-70 KIT (EIA METHOD)1995-02-22
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SS-A KIT (EIA METHOD)1995-02-22
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SS-B KIT (EIA METHOD)1995-02-22
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)1994-10-03
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ACL IGA CALIBRATOR1994-06-30
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)1994-04-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD01993-07-16
HEMAGEN DIAGNOSTICS, INC.
Analyst Physicians Office Profiler1992-12-12
HEMAGEN DIAGNOSTICS, INC.
Analyst Benchtop Clinical Chemistry Analyser1992-12-12
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA [JO-1] KIT (EIA METHOD)1992-04-07
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)1992-03-17
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCL-70 KIT (EIA METHOD)1992-02-12
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)1991-12-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREENING KIT (EIA METHOD)1991-12-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREENING KIT1991-03-06
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA [JO-I] KIT1990-05-18
HEMAGEN DIAGNOSTICS, INC.
SERATEST ENA [SSA] KIT1990-02-23
Hemagen Diagnostics, Inc.
Blood Irradiator1989-12-11
HEMAGEN DIAGNOSTICS, INC.
SERATEST ENA [SCL-70] KIT1989-08-02
HEMAGEN DIAGNOSTICS, INC.
SERATEST ENA [SS-B] KIT1986-08-19
HEMAGEN DIAGNOSTICS, INC.
SERATEST RF (HEMAGGLUTINATION) KIT1986-04-22

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