FDA.reportPublic FDA data

Chagas Kit EIA Method

Primary DI
G52266101
Brand
Chagas Kit EIA Method
Company
Hemagen Diagnostics, Inc.
Model
66101L
Device description
Presumptive qualitative ELISA for the detection of circulating antibodies to T. Cruzi.
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIUEnzyme Linked Immunosorbent Assay, T. Cruzi

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIUEnzyme Linked Immunosorbent Assay, T. CruziMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K930272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K930272000HEMAGEN CHAGAS' KIT (EIA METHOD)Hemagen Diagnostics, Inc.1995-05-19MIU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G52266101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Trypanosoma cruzi total antibody IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to the parasitic protozoan Trypanosoma cruzi in a clinical specimen using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

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
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
G5229030001Chlamydia trachomatis / C. trach IgG IFA 96 Test9030002023-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B379CP0501Chagas Detect™ Plus Rapid TestINBIOS INTERNATIONAL, INCMIU2018-09-24
10758750007745ORTHOORTHO-CLINICAL DIAGNOSTICS, INC.MIU2016-08-24