Device
Teco Diagnostics Infectious Mononucleosis (IM) Latex Test is a manual latex agglutination slide test intended to be used for the qualitative and semi-quantitative determination of...
Manufacturer
TECO DIAGNOSTICS
TECO DIAGNOSTICS
Model: IML-50
Catalog: IML-50
DI: 10673486014068
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Teco Diagnostics Infectious Mononucleosis (IM) Latex Test is a manual latex agglutination slide test intended to be used for the qualitative and semi-quantitative determination of human heterophile antibodies (HE) associated with IM in human serum.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4dac32fc-91c7-4a82-85a4-54171190e5ec
Distribution Status:
In Commercial Distribution
DUNS Number:
185067774
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:
10673486014068
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 49688
Name: Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Definition:
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of heterophile antibodies produced in response to Epstein-Barr virus (EBV) in a clinical specimen, using an agglutination method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.
FDA Product Codes
KTN
System, Test, Infectious Mononucleosis
Premarket Submissions
Submission Number:
K932551
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