Device
Presumptive qualitative ELISA for the detection of circulating antibodies to T. Cruzi.
Manufacturer
Hemagen Diagnostics, Inc.
Hemagen Diagnostics, Inc.
Model: 66101L
DI: G52266101
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
Presumptive qualitative ELISA for the detection of circulating antibodies to T. Cruzi.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
be90a319-0c33-4034-9afb-56456463d57b
Distribution Status:
In Commercial Distribution
DUNS Number:
147827216
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
G52266101
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 66466
Name: Trypanosoma cruzi total antibody IVD, kit, enzyme immunoassay (EIA)
Definition:
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.
FDA Product Codes
MIU
Enzyme Linked Immunosorbent Assay, T. Cruzi
Premarket Submissions
Submission Number:
K930272
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling Low - @attributes - Value:
2
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
8
Storage Handling - Storage Handling Type:
Storage Environment Temperature