MONOSPOT Latex is a one step rapid latex particle agglutination test for the qualitative and semiquantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma.

MONOSPOT Latex is a one step rapid latex particle agglutination test for the qualitative and semiquantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma.
MONOSPOT Latex - 776150

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KTN

Device Name: System, Test, Infectious Mononucleosis

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.5640

Third Party Flag: Y

Medical Specialty: IM

Device Id: 00840733101298

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A