HEMAGEN DIAGNOSTICS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1181055	1181055	HEMAGEN DIAGNOSTICS, INC.	1	N	2026-01-01	2900 LOCH RAVEN RD Baltimore MD US 21218

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
G52266101	Chagas Kit EIA Method - Presumptive qualitative ELISA for the detection of circulating antibodies to T. Cruzi.	443 367 5500	customerservice@hemagen.com
G5229021111	Cytomegalovirus / CMV IgG IFA 96 Test - For the detection and titration of cytomegalovirus (CMV) IgG antibodies in human sera	443 367 5500	customerservice@hemagen.com
G5229021121	Cytomegalovirus / CMV IgM IFA 96 Test - For the detection and titration of cytomegalovirus (CMV) IgM antibodies in human sera	443 367 5500	customerservice@hemagen.com
G5229023441	ANA/HEp-2 IgG IFA 96 Test - For the detection and titration of anti-nuclear IgG antibodies in human sera	443 367 5500	customerservice@hemagen.com

hemagen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
1597	1004956859	K992243	VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT	MSV	1999-08-30
1597	1252161771	K992241	VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT	MSV	1999-08-30
1597	1459387985	K992224	VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT	MSV	1999-08-30
1597	1842461000	K973824	VIRGO PANCO KIT	MOB	1997-11-13
1597	1681318805	K973823	PR 3 ANTIBODY KIT	MOB	1997-11-13
1597	1216075719	K973822	VIRGO ANCA SCREEN KIT	MOB	1997-11-13
1597	1445699038	K971909	VIRGO AMA ELISA KIT	DBM	1997-06-20
1597	1685376091	K971039	HEMAGEN ANTI CARDIOLIPIN SCREEN	MID	1997-06-03
1597	1519054976	K962836	HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD)	DHR	1996-09-12
1597	1194220214	K962276	HEMAGEN ENA DSDNA KIT (EIA METHOD)	DHN	1996-12-05
1597	1403387405	K960324	HEMAGEN CRP 150 KIT (EIA METHOD)	DCK	1996-03-12
1597	1858061868	K952077	HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)	LLL	1995-06-05
1597	1941207891	K952076	HEMAGEN ENA SCREENING KIT (EIA METHOD)	LLL	1995-06-05
1597	2062147485	K950414	HEMAGEN ENA SM/RMP KIT (EIA METHOD)	LLL	1995-03-29
1597	1559455029	K946124	HEMAGEN ENA JO-1 KIT (EIA METHOD)	LLL	1995-02-22
1597	1340936697	K946123	HEMAGEN ENA SM KIT (EIA METHOD)	LLL	1995-02-22
1597	1158735963	K946122	HEMAGEN ENA SCL-70 KIT (EIA METHOD)	LLL	1995-02-22
1597	1208198245	K946121	HEMAGEN ENA SS-A KIT (EIA METHOD)	LLL	1995-02-22
1597	1183383328	K946120	HEMAGEN ENA SS-B KIT (EIA METHOD)	LLL	1995-02-22
1597	1206780116	K944438	HEMAGEN CMV IGG KIT	LFZ	1997-02-20
1597	1288478944	K944288	HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)	DCK	1994-10-03
1597	1381288259	K941840	HEMAGEN ACL IGA CALIBRATOR	MID	1994-06-30
1597	1597950453	K935828	HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)	LLL	1994-04-20
1597	1309493859	K932373	HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0	MID	1993-07-16
1597	1025885623	K930272	HEMAGEN CHAGAS' KIT (EIA METHOD)	MIU	1995-05-19
1597	1581125020	K915420	HEMAGEN ENA [JO-1] KIT (EIA METHOD)	LLL	1992-04-07
1597	1053799282	K915282	HEMAGEN ENA SCL-70 KIT (EIA METHOD)	LLL	1992-02-12
1597	1244870200	K915272	HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)	LJM	1992-03-17
1597	1012566314	K915234	HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD)	LLL	1991-12-20
1597	1159101484	K915058	HEMAGEN ENA SCREENING KIT (EIA METHOD)	LLL	1991-12-20
1597	1337246829	K910232	HEMAGEN ENA SCREENING KIT	LLL	1991-03-06
1597	1934551690	K902139	HEMAGEN ENA [JO-I] KIT	DHN	1990-05-18
1597	1000425682	K901017	DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI	JFJ	1990-05-15
1597	1014476798	K900617	SERATEST ENA [SSA] KIT	LLL	1990-02-23
1597	1777032249	K894411	SERATEST ENA [SCL-70] KIT	LKJ	1989-08-02
1597	1344262529	K884700	ANALYST THYROXINE (T4) ROTOR	KLI	1989-01-27
1597	1457665779	K884170	ANALYST THEOPHYLLINE CALIBRATOR	DLJ	1988-11-16
1597	2000446028	K884169	DU PONT ANALYST THYROID ROTOR	CEL	1989-01-24
1597	1796207448	K884168	ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA.	JIS	1988-11-29
1597	1500215986	K884002	ANALYST THEOPHYLLINE ROTOR	KLS	1988-10-31
1597	1119549611	K871265	ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL	LBS	1987-08-13
1597	1317592990	K862700	SERATEST ENA [SS-B] KIT	LLL	1986-08-19
1597	1210616238	K862274	ANALYST ANALYTICAL TEST ROTORS	CIC	1986-07-29
1597	2069434559	K861567	CONTROL SERA LEVEL VALUES (MG/DL)	JJY	1986-05-23
1597	2065259278	K855221	SERATEST RF (HEMAGGLUTINATION) KIT	DHR	1986-04-22
1597	1874076248	K854523	ANALYST PHYSICIAN'S OFFICE PROFILER	JJG	1986-01-08
1597	1016109916	K844743	SERATEST ENA(RNP/SM) DETERMINATION	LLL	1985-02-04
1597	1840231111	K842563	SERATEST DNA DETERMINATION	LKJ	1984-10-25
1597	1716436746	K841127	VIRGO REAGENTS INDIRECT FLUORSCENT	DHN	1984-04-25
1597	1007113456	K831924	ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS	LKT	1983-08-11
1597	1732170369	K822826	ANTIBODY TO MUMPS VIRUS IFA TEST	GRA	1982-12-03
1597	1573943841	K821249	ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS	GRE	1982-07-30
1597	1061990861	K811570	ANTIBODY TO CHLAMYDIA TRACHOMATIS	GPW	1981-07-23
1597	1557192104	K810860	ENI ANTIBODY TO EPSTEIN-BARR VIRUS	GNP	1981-05-05
1597	1470542434	K800787	ANTIBODY TO VARICELLA-ZOSTER VIRUS	GGW	1980-07-14
1597	1026695336	K792635	ANTIBODY TO RUBELLA VIRUS	GOK	1980-03-19
1597	1320240275	K791058	ANTIBODY TO HERPESVIRUS HOMINIS	GQO	1979-09-07
1597	1293708841	K771376	IFA ANTI-NDNA	DHN	1977-10-18
1597	1204927056	K011126	RAICHEM CREATININE URINE STANDARD	JIT	2001-05-02
1597	2027119623	K010864	ANALYST PANELS + ANALYTICAL TEST ROTOR	KHS	2001-05-21
1597	1139682216	K003012	RAICHEM PHOSPORUS REAGENT	CEO	2000-10-25
1597	1874835975	BK940035
1597	1843326990	BK890028
1597	1001883941
1597	1057116095
1597	1141875686
1597	1514574405
1597	1557742558
1597	1652124293
1597	1756679997
1597	1819913353
1597	1911576668
1597	2044722404

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LLL	17	1995-06-05
DHN	4	1996-12-05
MSV	3	1999-08-30
MOB	3	1997-11-13
MID	3	1997-06-03
DHR	2	1996-09-12
DCK	2	1996-03-12
LKJ	2	1989-08-02
KHS	1	2001-05-21
JIT	1	2001-05-02
CEO	1	2000-10-25
DBM	1	1997-06-20
LFZ	1	1997-02-20
MIU	1	1995-05-19
LJM	1	1992-03-17
JFJ	1	1990-05-15
KLI	1	1989-01-27
CEL	1	1989-01-24
JIS	1	1988-11-29
DLJ	1	1988-11-16
KLS	1	1988-10-31
LBS	1	1987-08-13
CIC	1	1986-07-29
JJY	1	1986-05-23
JJG	1	1986-01-08
LKT	1	1983-08-11
GRA	1	1982-12-03
GRE	1	1982-07-30
GPW	1	1981-07-23
GNP	1	1981-05-05
GGW	1	1980-07-14
GOK	1	1980-03-19
GQO	1	1979-09-07

PMN#

RAICHEM GLUCOSE UV (LIQUID)
2004-06-30
HEMAGEN DIAGNOSTICS, INC.
RAICHEM CALCIUM (OCPC) LIQUID REAGENT
2004-06-25
HEMAGEN DIAGNOSTICS, INC.
RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
2003-06-16
HEMAGEN DIAGNOSTICS, INC.
RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER
2002-12-24
HEMAGEN DIAGNOSTICS, INC.
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
2002-09-17
HEMAGEN DIAGNOSTICS, INC.
RAICHEM LIPID CALIBRATOR
2002-09-03
HEMAGEN DIAGNOSTICS, INC.
RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
2002-07-29
HEMAGEN DIAGNOSTICS, INC.
MODIFICATION TO RAICHEM CALCIUM REAGENT
2002-07-19
HEMAGEN DIAGNOSTICS, INC.
RAICHEM BUN RATE REAGENT
2001-10-15
HEMAGEN DIAGNOSTICS, INC.
RAICHEM GLUCOSE UV REAGENT
2001-10-15
HEMAGEN DIAGNOSTICS, INC.
ANALYST PANELS + ANALYTICAL TEST ROTOR
2001-05-21
HEMAGEN DIAGNOSTICS, INC.
RAICHEM CREATININE URINE STANDARD
2001-05-02
HEMAGEN DIAGNOSTICS, INC.
RAICHEM PHOSPORUS REAGENT
2000-10-25
HEMAGEN DIAGNOSTICS, INC.
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
1999-08-30
HEMAGEN DIAGNOSTICS, INC.
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
1999-08-30
HEMAGEN DIAGNOSTICS, INC.
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
1999-08-30
HEMAGEN DIAGNOSTICS, INC.
VIRGO PANCO KIT
1997-11-13
HEMAGEN DIAGNOSTICS, INC.
VIRGO ANCA SCREEN KIT
1997-11-13
HEMAGEN DIAGNOSTICS, INC.
PR 3 ANTIBODY KIT
1997-11-13
HEMAGEN DIAGNOSTICS, INC.
RAICHEM PREALBUMIN SPIA
1997-08-28
HEMAGEN DIAGNOSTICS, INC.
VIRGO AMA ELISA KIT
1997-06-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ANTI CARDIOLIPIN SCREEN
1997-06-03
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN CMV IGG KIT
1997-02-20
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, CMV
1996-07-15
Hemagen Diagnostics, Inc.
HEMAGEN CRP 150 KIT (EIA METHOD)
1996-03-12
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREENING KIT (EIA METHOD)
1995-06-05
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREEN-6 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 SS-B KIT (EIA METHOD)
1995-02-22
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SS-A 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 JO-1 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 CALIBRATOR
1994-06-30
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN ENA SCREEN-6 KIT (EIA METHOD)
1994-04-20
HEMAGEN DIAGNOSTICS, INC.
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
1993-07-16
HEMAGEN DIAGNOSTICS, INC.

52 records. Showing 1-40. Next

GUDID#

Chagas Kit EIA Method - Presumptive qualitative ELISA for the detection of circulating antibodies to T. Cruzi.
Hemagen Diagnostics, Inc.
2026-05-11
ANA/HEp-2 IgG IFA 96 Test - For the detection and titration of anti-nuclear IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
ANA/HEp-2 IgG IFA 180 Test - For the detection and titration of anti-nuclear IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
ANA/HEp-2 IgG IFA 600 Test - For the detection and titration of anti-nuclear IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
ANA/HEp-2 IgG IFA 1200 Test - For the detection and titration of anti-nuclear IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
ANA/HEp-2 IgG IFA 120 Test - For the detection and titration of anti-nuclear IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Cytomegalovirus / CMV IgG IFA 96 Test - For the detection and titration of cytomegalovirus (CMV) IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-06
Cytomegalovirus / CMV IgM IFA 96 Test - For the detection and titration of cytomegalovirus (CMV) IgM antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-06
Toxo IgG IFA 120 Test - For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
2023-10-05
Toxo IgG IFA 204 Test - For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
2023-10-05
Toxo IgG IFA Slide Only Kit - For the detection and titration of Toxoplasma gondii IgG antibodies
Hemagen Diagnostics, Inc.
2023-10-05
Anti-nDNA IgG IFA 96 Test - For the detection and titration of anti-native DNA antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test - For the detection and titration of HSV-1 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit - For the detection and titration of HSV-1 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test - For the detection and titration of HSV-2 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit - For the detection and titration of HSV-2 IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Rubella IgG IFA 96 Test - For the detection and titration of rubella virus IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Rubella IgG IFA Slide Only Kit - For the detection and titration of rubella virus IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Varicella-Zoster Virus / VZV IgG IFA 96 Test - For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit - For the detection and titration of antibodies to varicella-zoster virus in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Chlamydia trachomatis / C. trach IgG IFA 96 Test - For the detection and titration of C. trachomatis IgG antibodies in human sera.
Hemagen Diagnostics, Inc.
2023-10-05
Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit - For the detection and titration of C. trachomatis IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Measles IgG IFA 96 Test - For the detection and titration of measles IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Measles IgG IFA Slide Only Kit - For the detection and titration of measles IgG antibodies in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Mumps IgG IFA 96 Test - For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
2023-10-05
Mumps IgG IFA Slide Only Kit - For the detection and titration of IgG antibodies to mumps virus in human sera
Hemagen Diagnostics, Inc.
2023-10-05