FDA.reportPublic FDA data

Mumps IgG IFA Slide Only Kit

Primary DI
G5229032011
Brand
Mumps IgG IFA Slide Only Kit
Company
Hemagen Diagnostics, Inc.
Model
903201
Device description
For the detection and titration of IgG antibodies to mumps virus in human sera
Published
2023-10-05
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
GRAAntiserum, Fluorescent, Mumps Virus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GRAAntiserum, Fluorescent, Mumps VirusMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K822826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K822826000ANTIBODY TO MUMPS VIRUS IFA TESTElectro-Nucleonics Laboratories, Inc.1982-12-03GRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G5229032011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Mumps virus immunoglobulin G (IgG) 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 G (IgG) antibodies to Mumps virus 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
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
G5229021121Cytomegalovirus / CMV IgM IFA 96 Test9021122023-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G5229032001Mumps IgG IFA 96 TestHemagen Diagnostics, Inc.GRA2023-10-05
04053252364068Light Diagnostics ™ Mumps Control SlidesEMD Millipore CorporationGRA2022-12-01
04053252282713Light Diagnostics ™ Mumps Monoclonal AntibodyEMD Millipore CorporationGRA2022-11-30
04061839704138Light Diagnostics ™ Mumps Control SlideEMD Millipore CorporationGRA2022-11-30
04053252329746Light Diagnostics™ Mumps IFA KitEMD Millipore CorporationGRA2022-11-28
04049016057468Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057475Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057482Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057499Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057505Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057512Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057529Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016057536Anti-Mumps virus IFA (IgM)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
04049016079514Anti-Mumps virus IFA (IgG)EUROIMMUN Medizinische Labordiagnostika AGGRA2016-09-24
00813545026035Mumps IgG 120 Test Kit SCIMEDX CORPORATIONGRA2016-09-21
00813545026059Mumps 10 Well; 10 pk SCIMEDX CORPORATIONGRA2016-09-21
B110MU80060Mumps Virus Antigen Substrate, 6 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MU80120Mumps Virus Antigen Substrate, 12 wells, For IFA Test SystemBion Enterprises, Ltd.GRA2016-09-12
B110MUG1200Mumps IgG Test System, 120 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG600Mumps IgG Test System, 60 TestsBion Enterprises, Ltd.GRA2016-09-12
B110MUG80200Mumps IgG ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUM80300Mumps IgM ControlBion Enterprises, Ltd.GRA2016-09-12
B110MUN80100Mumps Negative ControlBion Enterprises, Ltd.GRA2016-09-12