FDA.reportPublic FDA data

Rubella IgG IFA Slide Only Kit

Primary DI
G5229027011
Brand
Rubella IgG IFA Slide Only Kit
Company
Hemagen Diagnostics, Inc.
Model
902701
Device description
For the detection and titration of rubella virus IgG antibodies 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
LSDRubella, Other Assays

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSDRubella, Other AssaysMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K792635000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K792635000ANTIBODY TO RUBELLA VIRUSElectro-Nucleonics Laboratories, Inc.1980-03-19GOK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G5229027011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rubella 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 Rubella 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
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
G5229027001Rubella IgG IFA 96 TestHemagen Diagnostics, Inc.LSD2023-10-05