FDA.reportPublic FDA data

Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit

Primary DI
G5229030011
Brand
Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit
Company
Hemagen Diagnostics, Inc.
Model
903001
Device description
For the detection and titration of C. trachomatis 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
LJPAntiserum, Fluorescent, Chlamydia Trachomatis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJPAntiserum, Fluorescent, Chlamydia TrachomatisMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811570000ANTIBODY TO CHLAMYDIA TRACHOMATISElectro-Nucleonics Laboratories, Inc.1981-07-23GPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G5229030011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chlamydia trachomatis 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 Chlamydia trachomatis bacteria 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
05032384503032IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDEOXOID LIMITEDLJP2024-07-03
05032384502943IMAGEN ChlamydiaOXOID LIMITEDLJP2024-06-19
G5229030001Chlamydia trachomatis / C. trach IgG IFA 96 TestHemagen Diagnostics, Inc.LJP2023-10-05
00847865001410PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001427PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001434PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865001441PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
00847865012775PathfinderBio-RAD Laboratories, Inc.LJP2023-01-04
05056080501901PathoDx Chlamydia trachomatis Control SlideREMEL EUROPE LIMITEDLJP2021-07-21
05056080501918PathoDx Chlamydia Culture ConfirmationREMEL EUROPE LIMITEDLJP2021-07-21
05056080501925PathoDx Chlamydia trachomatis Direct SpecimenREMEL EUROPE LIMITEDLJP2021-07-21
30014613330547D3DIAGNOSTIC HYBRIDS, INC.LJP2018-08-30
30014613330554D3DIAGNOSTIC HYBRIDS, INC.LJP2018-07-22