FDA.reportPublic FDA data

Cytomegalovirus / CMV IgM IFA 96 Test

Primary DI
G5229021121
Brand
Cytomegalovirus / CMV IgM IFA 96 Test
Company
Hemagen Diagnostics, Inc.
Model
902112
Device description
For the detection and titration of cytomegalovirus (CMV) IgM antibodies in human sera
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GQHAntigen, Cf (Including Cf Control), Cytomegalovirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GQHAntigen, Cf (Including Cf Control), CytomegalovirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G5229021121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen, using a fluorescent immunoassay method.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
443 367 5500customerservice@hemagen.com

Regulatory Flags#

DUNS number
147827216
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G52266101Chagas Kit EIA Method66101L2026-05-11
G5229023441ANA/HEp-2 IgG IFA 96 Test9023442023-10-05
G5229023451ANA/HEp-2 IgG IFA 180 Test9023452023-10-05
G5229023601ANA/HEp-2 IgG IFA 600 Test9023602023-10-05
G5229023701ANA/HEp-2 IgG IFA 1200 Test9023702023-10-05
G5229023901ANA/HEp-2 IgG IFA 120 Test9023902023-10-05
G5229021111Cytomegalovirus / CMV IgG IFA 96 Test9021112023-10-06
G5229020101Toxo IgG IFA 120 Test9020102023-10-05
G5229020201Toxo IgG IFA 204 Test9020202023-10-05
G5229020211Toxo IgG IFA Slide Only Kit9020212023-10-05
G5229024201Anti-nDNA IgG IFA 96 Test9024202023-10-05
G5229025001Herpes Simplex Virus Type 1 / HSV-1 IgG IFA 96 Test9025002023-10-05
G5229025011Herpes Simplex Virus Type 1 / HSV-1 IgG IFA Slide Only Kit9025012023-10-05
G522902600Herpes Simplex Virus Type 2 / HSV-2 IgG IFA 96 Test9026002023-10-05
G5229026011Herpes Simplex Virus Type 2 / HSV-2 IgG IFA Slides Only Kit9026012023-10-05
G5229027001Rubella IgG IFA 96 Test9027002023-10-05
G5229027011Rubella IgG IFA Slide Only Kit9027012023-10-05
G5229028001Varicella-Zoster Virus / VZV IgG IFA 96 Test9028002023-10-05
G5229028011Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit9028012023-10-05
G5229030001Chlamydia trachomatis / C. trach IgG IFA 96 Test9030002023-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229021111Cytomegalovirus / CMV IgG IFA 96 TestHemagen Diagnostics, Inc.GQH2023-10-06
04053252589768Light Diagnostics CMV Control Slides (5 pack)EMD Millipore CorporationGQH2020-04-17
04053252671074Light Diagnostics CMV IFA ReagentEMD Millipore CorporationGQH2020-04-17
04053252731730Light Diagnostics Anti-mouse IGG:FITCEMD Millipore CorporationGQH2020-04-17
04053252737183Light Diagnostics Mouse Anti-CMV Monoclonal AntibodyEMD Millipore CorporationGQH2020-04-17
04061841047445Light Diagnostics CMV Control SlideEMD Millipore CorporationGQH2020-04-17
03573026390273ARGENE® CINAkit HCMV ppUL83 USBIOMERIEUX SAGQH2016-10-17
04053252676024Light Diagnostics™ CMV IFA KitEMD Millipore CorporationGQH2016-09-26
00813545025489Cytomegalovirus IgG 120 Tests SCIMEDX CORPORATIONGQH2016-09-20
00813545025502Cytomegalovirus 10wl/10 pk SCIMEDX CORPORATIONGQH2016-09-20
B110CM20120Cytomegalovirus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GQH2016-09-12
B110CMG1200CMV IgG Test System, 120 TestsBion Enterprises, Ltd.GQH2016-09-12
B110CMG20200CMV IgG ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMM20300CMV IgM ControlBion Enterprises, Ltd.GQH2016-09-12
B110CMN20100CMV Negative ControlBion Enterprises, Ltd.GQH2016-09-12