Data / Medical devices / United States / Hemagen Diagnostics, Inc.

Hemagen Diagnostics, Inc.: FDA-registered device maker in Baltimore, MD, United States, 61 510(k) clearances

Name: Hemagen Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hemagen Diagnostics, Inc. is registered with the FDA (registration 1181055) in Baltimore, MD, United States. It lists 43 device types. The FDA files 61 510(k) clearances under its listings, the newest dated May 21, 2001. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Hemagen Diagnostics, Inc.

FDA registration number: 1181055
Address: 2900 Loch Raven RD, Baltimore, MD, United States, 21218
Owner or operator: HEMAGEN DIAGNOSTICS, INC. (1221107)
Roles: Manufacturer
First device listed: December 12, 1992
Registered through: 2026
Brand names listed: ANA HEp-2 Kit, Analyst Analytical Rotor (T4) Thyroxine & Thyroxine Uptake Calibrator, Analyst Analytical Test Rotor (Chem 14), Analyst Analytical Thyroid Rotor, Analyst Benchtop Clinical Chemistry Analyser, Analyst Benchtop Clinical Chemistry Analyzer, Analyst Physicians Office Profiler, Analyst Test Rotors Cresolphthalein complexone, calcium and more

Devices it lists

Device	Product code	Class	Role	Source
Ammonium Molybdate And Ammonium Vanadate, Phospholipids	CEL	1	Manufacturer	accessdata.fda.gov
Analyzer, Chemistry, Centrifugal, For Clinical Use	JJG	1	Manufacturer	accessdata.fda.gov
Anti-Human Globulin, Fta-Abs Test	GMS	2	Manufacturer	accessdata.fda.gov
Antigen, Cf (Including Cf Control), Cytomegalovirus	GQH	2	Manufacturer	accessdata.fda.gov
Antigen, Cf, Psittacosis (Chlamydia Group)	GPW	1	Manufacturer	accessdata.fda.gov
Antigens, If, Toxoplasma Gondii	GLZ	2	Manufacturer	accessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	DBM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Antigen, Control	LKJ	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	DHN	2	Manufacturer	accessdata.fda.gov
Antisera, Cf, Herpesvirus Hominis 1,2	GQO	2	Manufacturer	accessdata.fda.gov
Antisera, Hai (Including Hai Control), Rubella	GOK	2	Manufacturer	accessdata.fda.gov
Antiserum, Cf, Epstein-Barr Virus	GNP	1	Manufacturer	accessdata.fda.gov
Antiserum, Fluorescent, Mumps Virus	GRA	1	Manufacturer	accessdata.fda.gov
Antiserum, Fluorescent, Rubeola	GRE	1	Manufacturer	accessdata.fda.gov
Bromcresol Green Dye-Binding, Albumin	CIX	2	Manufacturer	accessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And Control	DCK	2	Manufacturer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Manufacturer	accessdata.fda.gov
Catalytic Methods, Amylase	JFJ	2	Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Colorimetric Method, Lipoproteins	JHM	1	Manufacturer	accessdata.fda.gov
Cresolphthalein Complexone, Calcium	CIC	2	Manufacturer	accessdata.fda.gov
Diazo Colorimetry, Bilirubin	CIG	2	Manufacturer	accessdata.fda.gov
Enzymatic, Carbon-Dioxide	KHS	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Theophylline	KLS	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	LFZ	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunosorbent Assay, T. Cruzi	MIU	1	Manufacturer	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Manufacturer	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	LBS	1	Manufacturer	accessdata.fda.gov
MZB	MZB		Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer	accessdata.fda.gov
Phosphomolybdate (Colorimetric), Inorganic Phosphorus	CEO	1	Manufacturer	accessdata.fda.gov
Respiratory Syncytial Virus, Antigen, Antibody, Ifa	LKT	1	Manufacturer	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Manufacturer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Manufacturer	accessdata.fda.gov
Test, Donor, Cmv	MZE	2	Manufacturer	accessdata.fda.gov
Test, Time, Partial Thromboplastin	GGW	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 21, 2001	K010864	ANALYST PANELS + ANALYTICAL TEST ROTOR	KHS	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
May 2, 2001	K011126	RAICHEM CREATININE URINE STANDARD	JIT	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
October 25, 2000	K003012	RAICHEM PHOSPORUS REAGENT	CEO	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
August 30, 1999	K992243	VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT	MSV	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
August 30, 1999	K992241	VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT	MSV	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
August 30, 1999	K992224	VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT	MSV	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
November 13, 1997	K973824	VIRGO PANCO KIT	MOB	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
November 13, 1997	K973823	PR 3 ANTIBODY KIT	MOB	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
November 13, 1997	K973822	VIRGO ANCA SCREEN KIT	MOB	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
June 20, 1997	K971909	VIRGO AMA ELISA KIT	DBM	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
June 3, 1997	K971039	HEMAGEN ANTI CARDIOLIPIN SCREEN	MID	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 20, 1997	K944438	HEMAGEN CMV IGG KIT	LFZ	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
December 5, 1996	K962276	HEMAGEN ENA DSDNA KIT (EIA METHOD)	DHN	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
September 12, 1996	K962836	HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)	DHR	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
March 12, 1996	K960324	HEMAGEN CRP 150 KIT (EIA METHOD)	DCK	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
June 5, 1995	K952077	HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
June 5, 1995	K952076	HEMAGEN ENA SCREENING KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
May 19, 1995	K930272	HEMAGEN CHAGAS' KIT (EIA METHOD)	MIU	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
March 29, 1995	K950414	HEMAGEN ENA SM/RMP KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 22, 1995	K946124	HEMAGEN ENA JO-1 KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 22, 1995	K946123	HEMAGEN ENA SM KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 22, 1995	K946122	HEMAGEN ENA SCL-70 KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 22, 1995	K946121	HEMAGEN ENA SS-A KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 22, 1995	K946120	HEMAGEN ENA SS-B KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
October 3, 1994	K944288	HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)	DCK	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
June 30, 1994	K941840	HEMAGEN ACL IGA CALIBRATOR	MID	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
April 20, 1994	K935828	HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
July 16, 1993	K932373	HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0	MID	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
April 7, 1992	K915420	HEMAGEN ENA [JO-1] KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
March 17, 1992	K915272	HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)	LJM	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
February 12, 1992	K915282	HEMAGEN ENA SCL-70 KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
December 20, 1991	K915234	HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
December 20, 1991	K915058	HEMAGEN ENA SCREENING KIT (EIA METHOD)	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
March 6, 1991	K910232	HEMAGEN ENA SCREENING KIT	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
May 18, 1990	K902139	HEMAGEN ENA [JO-I] KIT	DHN	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
May 15, 1990	K901017	DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI	JFJ	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.	accessdata.fda.gov
February 23, 1990	K900617	SERATEST ENA [SSA] KIT	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
August 2, 1989	K894411	SERATEST ENA [SCL-70] KIT	LKJ	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
January 27, 1989	K884700	ANALYST THYROXINE (T4) ROTOR	KLI	Substantially Equivalent	The DU Pont Co.	accessdata.fda.gov
January 24, 1989	K884169	DU PONT ANALYST THYROID ROTOR	CEL	Substantially Equivalent	The DU Pont Co.	accessdata.fda.gov
November 29, 1988	K884168	ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.	JIS	Substantially Equivalent	The DU Pont Co.	accessdata.fda.gov
November 16, 1988	K884170	ANALYST THEOPHYLLINE CALIBRATOR	DLJ	Substantially Equivalent	The DU Pont Co.	accessdata.fda.gov
October 31, 1988	K884002	ANALYST THEOPHYLLINE ROTOR	KLS	Substantially Equivalent	The DU Pont Co.	accessdata.fda.gov
August 13, 1987	K871265	ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL	LBS	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.	accessdata.fda.gov
August 19, 1986	K862700	SERATEST ENA [SS-B] KIT	LLL	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
July 29, 1986	K862274	ANALYST ANALYTICAL TEST ROTORS	CIC	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.	accessdata.fda.gov
May 23, 1986	K861567	CONTROL SERA LEVEL VALUES (MG/DL)	JJY	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.	accessdata.fda.gov
April 22, 1986	K855221	SERATEST RF (HEMAGGLUTINATION) KIT	DHR	Substantially Equivalent	Hemagen Diagnostics, Inc.	accessdata.fda.gov
January 8, 1986	K854523	ANALYST PHYSICIAN'S OFFICE PROFILER	JJG	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.	accessdata.fda.gov
February 4, 1985	K844743	SERATEST ENA(RNP/SM) DETERMINATION	LLL	Substantially Equivalent	Seragen Diagnostics, Inc.	accessdata.fda.gov
October 25, 1984	K842563	SERATEST DNA DETERMINATION	LKJ	Substantially Equivalent	Seragen Diagnostics, Inc.	accessdata.fda.gov
April 25, 1984	K841127	VIRGO REAGENTS INDIRECT FLUORSCENT	DHN	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
August 11, 1983	K831924	ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS	LKT	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
December 3, 1982	K822826	ANTIBODY TO MUMPS VIRUS IFA TEST	GRA	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
July 30, 1982	K821249	ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS	GRE	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
July 23, 1981	K811570	ANTIBODY TO CHLAMYDIA TRACHOMATIS	GPW	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
May 5, 1981	K810860	ENI ANTIBODY TO EPSTEIN-BARR VIRUS	GNP	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
July 14, 1980	K800787	ANTIBODY TO VARICELLA-ZOSTER VIRUS	GGW	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
March 19, 1980	K792635	ANTIBODY TO RUBELLA VIRUS	GOK	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
September 7, 1979	K791058	ANTIBODY TO HERPESVIRUS HOMINIS	GQO	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov
October 18, 1977	K771376	IFA ANTI-NDNA	DHN	Substantially Equivalent	Electro-Nucleonics Laboratories, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 21, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.