KTN · System, Test, Infectious Mononucleosis
Immunology · 21 CFR 866.5640 · Class 2
Overview
| Product Code | KTN |
|---|---|
| Device Name | System, Test, Infectious Mononucleosis |
| Regulation | 21 CFR 866.5640 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 59)
Showing 20 most recent of 59 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | SEKISUI Diagnostics, LLC | Jun 22, 2018 | SESE |
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | ACON Laboratories, Inc. | Feb 28, 2005 | SESE |
| K030215 | BIORAPID MONONUCLEOSIS | Instrumentation Laboratory CO | Feb 24, 2003 | SESE |
| K012901 | COLOR-MONOGEN | Instrumentation Laboratory CO | Sep 27, 2001 | SESE |
| K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | Oxoid , Ltd. | Jan 28, 1999 | SESE |
| K981946 | CLEARVIEW IM | Unipath , Ltd. | Dec 10, 1998 | SESE |
| K972457 | MONOCOL/LEX-IM TEST | Immunostics Inc., | Dec 1, 1997 | SESE |
| K972231 | OSOM MONO TEST 143 | Wyntek Diagnostics, Inc. | Aug 26, 1997 | SESE |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | Genzyme Diagnostics | Feb 25, 1997 | SESE |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | Princeton BioMeditech Corp. | Feb 4, 1997 | SESE |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Consolidated Technologies, Inc. | Sep 24, 1996 | SESE |
| K930778 | IMMUNOCARD MONO | Meridian Diagnostics, Inc. | Dec 27, 1993 | SESE |
| K932688 | EYE SPOT IM TEST | J.S. Medical Assoc. | Sep 8, 1993 | SESE |
| K932551 | ACCUTEX IM LATEX TEST | J.S. Medical Assoc. | Aug 9, 1993 | SESE |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | Princeton Biomedix | Feb 23, 1993 | SESE |
| K924037 | ACCUTEX IM RBC TEST | J.S. Medical Assoc. | Nov 2, 1992 | SESE |
| K923767 | PULSE IM RED CELL TEST | Pulse Scientific, Inc. | Oct 16, 1992 | SESE |
| K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | Simplicity Diagnostics, Inc. | Oct 5, 1992 | SESE |
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | Ampcor, Inc. | Jul 14, 1992 | SESE |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | Ampcor, Inc. | Jul 14, 1992 | SESE |
Top Applicants
- Texas Immunology, Inc. — 3 clearances
- J.S. Medical Assoc. — 3 clearances
- Armkel, LLC — 3 clearances
- Ampcor, Inc. — 3 clearances
- Unipath , Ltd. — 2 clearances
