HEMAGEN DIAGNOSTICS, INC.

FDA Device Registration & Listing · Baltimore, MD, US · Registration 1181055

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1181055
FEI Number
1181055
Entity Name
HEMAGEN DIAGNOSTICS, INC.
City/State/Country
Baltimore, MD, US
Establishment Address
2900 LOCH RAVEN RD, Baltimore, MD 21218, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
HEMAGEN DIAGNOSTICS, INC. (Owner Number: 1221107)
Owner / Operator Contact Address
2900 LOCH RAVEN RD, --, Baltimore, MD 21218, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K946121
PMA Number
N/A

All Registered Proprietary Names

Hemagen Cytomegalovirus (CMV) IgM Kit Virgo Cytomegalovirus (CMV) IgM Kit Hemagen Chagas EIA Kit Extractable Antinuclear Antibody (ENA) Screening Kit Virgo RNP/sm Kit Hemagen RNP/sm Kit HA Hemagen RNP/sm Kit Virgo RNP/sm Kit HA Extractable Antinuclear Antibody (ENA) Screening Kit Extractable Antinuclear Antibody (ENA) Screening Kit, Scl-70 Kit Virgo RF Kit Hemagen RF Kit Virgo RF Kit HA Hemagen RF Kit HA CMV PK System Controls Extractable Antinuclear Antibody (ENA) Screening Kit, Sm Extractable Antinuclear Antibody (ENA) Screening Kit Virgo Anti-Cardiolipin IgA Antibody Kit Hemagen Anti-Cardiolipin IgA Antibody Kit Virgo MPO (P Anca) Antibody Kit Hemagen MPO (P Anca) Antibody Kit Calibrator Standard Hemagen Analyst Multi Analyste Serum Control Anti Mitochondrial Antibody Indirect Immunofluorescent Test Kit Extractable Antinuclear Antibody (ENA) Screening Kit, SmRNP Beta 2 Glycoprotein IgM Elisa Test Kit Hemagen Herpes Simplex Virus (HSV) 1 & 2 Kit Virgo Herpes Simplex Virus (HSV) 1&2 Kit Herpes Simplex Virus (HSV) 1&2 Kit Respiratory Syncytial Virus (RSV) Test Kit Analyst Benchtop Clinical Chemistry Analyzer Hemagen ds DNA Kit HA Virgo ds DNA Kit HA Hemagen ds DNA Kit Virgo ds DNA Kit IgM universal Conjugate Virgo Respiratory Syncytial Virus(RSV) Kit Respiratory Syncytial Virus(RSV) Kit Hemagen Respiratory Syncytial Virus(RSV) Kit Measles (Rubeola) Test Kit Antinuclear Antibody, Indirect Immunofluorescent nDNA kit Beta 2 Glycoprotein IgG Elisa Test Kit Lipid Analyst Thyroxine (T4) Rotor Rheumatoid Factor Test Kit Virgo Anti-Cardiolipin Antibody IgG IgM Kit Hemagen Anti-Cardiolipin Antibody IgG IgM Kit Extractable Antinuclear Antibody (EIA) Screening Kit, Jo-1 Beta 2 Glycoprotein IgA Elisa Test Kit Extractable Antinuclear Antibody (EIA) Screening Kit, Jo-1 Hemagen ENA Jo 1 Kit HA Virgo ENA Jo 1 Kit HA Hemagen ENA Jo 1 Kit Virgo ENA Jo 1 Kit Virgo Antimitochondrial (AMA) KIt Hemagen Antimitochondrial (AMA) KIt Lipid Rotor Analyst Theophylline Rotor Analyst Physicians Office Profiler Analyst Benchtop Clinical Chemistry Analyser Panels Plus Hemagen Scl - 70 EIA Kit Virgo Scl - 70 EIA Kit Hemagen ENA Screening Kit Virgo ENA Screening Kit HA Hemagen ENA Screening Kit HA Virgo ENA Screening Kit Hemagen Mumps KIt IFA Method Virgo Mumps Kit IFA Method Analyst Theophylline Calibrator Extractable Antinuclear Antibody (ENA) Screening Kit Analyst Test Rotors Cresolphthalein complexone, calcium VZV IgG IFA Virgo ANA HEp-2 Kit Hemagen ANA HEp-2 Kit ANA HEp-2 Kit Hemagen ANA HEp-2 Kit, IFA Method Extractable Antinuclear Antibody (ENA) Screening Kit, SmRNP Virgo Epstein-Barr Virus Kit Hemagen Epstein-Barr Virus Kit Hemagen c.trach IFA Kit Virgo c.trach Kit Hemagen Chlamydia Trachomatis IFA Kit Virgo Chlamydia Trachomatis IFA Kit Analyst Analytical Rotor (T4) Thyroxine & Thyroxine Uptake Calibrator Analyst Analytical Thyroid Rotor Hemagen Toxoplasma (Toxo) Kit Virgo Toxoplasma (Toxo) Kit Extractable Antinuclear Antibody (EIA) Screening Kit, Scl-70 Extractable Antinuclear Antibody (ENA) Screening Kit, SS-A

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GQH Antigen, Cf (Including Cf Control), Cytomegalovirus Microbiology Class 2 866.3175 2009-12-02
MIU Enzyme Linked Immunosorbent Assay, T. Cruzi Microbiology Class 1 866.3870 2009-12-02
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2009-12-02
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2009-12-02
MZE Test, Donor, Cmv Unknown Class 2 N/A 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2009-12-02
MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) Immunology Class 2 866.5660 2009-12-02
JIT Calibrator, Secondary Clinical Chemistry Class 2 862.1150 2016-11-06
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2009-12-02
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2016-11-06
GQO Antisera, Cf, Herpesvirus Hominis 1,2 Microbiology Class 2 866.3305 2009-12-02
LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa Microbiology Class 1 866.3480 2016-11-06
JJG Analyzer, Chemistry, Centrifugal, For Clinical Use Clinical Chemistry Class 1 862.2140 2016-11-06
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2009-12-02
PPM General Purpose Reagent Pathology Class 1 864.4010 2009-05-07
LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa Microbiology Class 1 866.3480 1995-07-11
GRE Antiserum, Fluorescent, Rubeola Microbiology Class 1 866.3520 2016-11-06
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2016-11-06
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2016-11-06
JHM Colorimetric Method, Lipoproteins Clinical Chemistry Class 1 862.1475 1998-09-08
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine Clinical Chemistry Class 2 862.1700 2016-11-06
DHR System, Test, Rheumatoid Factor Immunology Class 2 866.5775 2016-11-06
MID System, Test, Anticardiolipin Immunological Immunology Class 2 866.5660 2009-12-02
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) Immunology Class 2 866.5660 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2009-12-02
DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5090 2009-12-02
LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl Clinical Chemistry Class 1 862.1475 2009-12-02
KLS Enzyme Immunoassay, Theophylline Clinical Toxicology Class 2 862.3880 2016-11-06
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 1992-12-12
CIX Bromcresol Green Dye-Binding, Albumin Clinical Chemistry Class 2 862.1035 2009-12-02
KHS Enzymatic, Carbon-Dioxide Clinical Chemistry Class 2 862.1160 2009-12-02
CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus Clinical Chemistry Class 1 862.1580 2009-12-02
CIG Diazo Colorimetry, Bilirubin Clinical Chemistry Class 2 862.1110 2009-12-02
LKJ Antinuclear Antibody, Antigen, Control Immunology Class 2 866.5100 2009-12-02
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2009-12-02
GRA Antiserum, Fluorescent, Mumps Virus Microbiology Class 1 866.3380 1995-07-11
DLJ Calibrators, Drug Specific Clinical Toxicology Class 2 862.3200 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
CIC Cresolphthalein Complexone, Calcium Clinical Chemistry Class 2 862.1145 2016-11-06
GGW Test, Time, Partial Thromboplastin Hematology Class 2 864.7925 2011-10-20
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2009-12-02
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Immunology Class 2 866.5100 2009-12-02
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2016-11-06
GNP Antiserum, Cf, Epstein-Barr Virus Microbiology Class 1 866.3235 2009-12-02
GPW Antigen, Cf, Psittacosis (Chlamydia Group) Microbiology Class 1 866.3120 2009-12-02
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2016-11-06
CEL Ammonium Molybdate And Ammonium Vanadate, Phospholipids Clinical Chemistry Class 1 862.1575 2016-11-06
GLZ Antigens, If, Toxoplasma Gondii Microbiology Class 2 866.3780 2009-12-02
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06
LLL Extractable Antinuclear Antibody, Antigen And Control Immunology Class 2 866.5100 2016-11-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HEMAGEN DIAGNOSTICS, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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K081789 Siemens Healthcare Diagnostics, Inc. DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR 2008-09-10
K103836 Siemens Healthcare Diagnostics, Inc. ENZYME II CALIBRATOR 2011-02-16
K103548 Siemens Healthcare Diagnostics, Inc. ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 2011-06-02

Related Recall Records

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Z-0034-2008 Louisville Apl Diagnostics Inc 2
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Z-0024-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
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Z-0024-2015 Siemens Healthcare Diagnostics, Inc. 2
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1181055. Last updated year: 2026. Please use registration number 1181055 when referencing this establishment in official correspondence.
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