Product code KTN
- Device name
- System, Test, Infectious Mononucleosis
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5640
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | SEKISUI Diagnostics, LLC | 2018-06-22 |
| K042272 | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | ACON Laboratories, Inc. | 2005-02-28 |
| K030215 | BIORAPID MONONUCLEOSIS | Instrumentation Laboratory CO | 2003-02-24 |
| K012901 | COLOR-MONOGEN | Instrumentation Laboratory CO | 2001-09-27 |
| K982634 | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | Oxoid , Ltd. | 1999-01-28 |
| K981946 | CLEARVIEW IM | Unipath , Ltd. | 1998-12-10 |
| K972457 | MONOCOL/LEX-IM TEST | Immunostics Inc., | 1997-12-01 |
| K972231 | OSOM MONO TEST 143 | Wyntek Diagnostics, Inc. | 1997-08-26 |
| K963425 | GENZYME DIAGNOSTICS CONTRAST MONO | Genzyme Diagnostics | 1997-02-25 |
| K961024 | BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB | Princeton BioMeditech Corp. | 1997-02-04 |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-24 |
| K930778 | IMMUNOCARD MONO | Meridian Diagnostics, Inc. | 1993-12-27 |
| K932688 | EYE SPOT IM TEST | J.S. Medical Assoc. | 1993-09-08 |
| K932551 | ACCUTEX IM LATEX TEST | J.S. Medical Assoc. | 1993-08-09 |
| K925183 | BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST | Princeton Biomedix | 1993-02-23 |
| K924037 | ACCUTEX IM RBC TEST | J.S. Medical Assoc. | 1992-11-02 |
| K923767 | PULSE IM RED CELL TEST | Pulse Scientific, Inc. | 1992-10-16 |
| K922726 | TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL | Simplicity Diagnostics, Inc. | 1992-10-05 |
| K922297 | INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST | Ampcor, Inc. | 1992-07-14 |
| K922296 | IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST | Ampcor, Inc. | 1992-07-14 |
| K920221 | HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY | Akers Research Corp. | 1992-03-13 |
| K902510 | CARDS O.S. MONO | Pacific Biotech, Inc. | 1990-07-16 |
| K902541 | MONO-LEX SYSTEM: INFECTIOUS MONONUCLEOSIS LATEX | Trinity Laboratories, Inc. | 1990-06-28 |
| K900625 | MONO-PLUS POSITIVE AND NEGATIVE CONTROL SET | Armkel, LLC | 1990-02-26 |
| K896926 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS | Quidel Corp. | 1990-01-26 |
| K895891 | DETECTADOT SYSTEM 2000 HETEROPHILE TEST | Gull Laboratories, Inc. | 1989-10-31 |
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Leeco Diagnostics, Inc. | 1989-10-31 |
| K894975 | IMMUNODOT INFECTIOUS MONONUCLEOSIS TEST | General Biometrics, Inc. | 1989-09-13 |
| K894793 | MONODEX | Cenogenics Corp. | 1989-08-21 |
| K893737 | DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS TEST | Quidel Corp. | 1989-06-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10673486014068 | Teco Diagnostics Infectious Mononucleosis (IM) Latex Test | TECO DIAGNOSTICS | 2026-05-21 |
| 20885380183635 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-08-29 |
| 00006136471325 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471196 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471202 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471301 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 00006136471318 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2017-10-27 |
| 30888277191895 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10304040024130 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10763924516299 | ACCUTEST Rapid Mono Test | JANT PHARMACAL CORPORATION | 2016-09-24 |
| 10859035006191 | Wampole ColorCard® Mono | ALERE NORTH AMERICA, LLC | 2016-09-24 |
| 00613647000281 | Sure-Vue | FISHER SCIENTIFIC COMPANY L.L.C. | 2016-09-24 |
| 08426950585350 | Monogen 150 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 08426950344773 | Color Mono 50 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 08426950001676 | Monogen 50 TESTS | BIOKIT, S.A. | 2016-09-23 |
| 10722355001255 | Detector Mono | Immunostics Company, Inc | 2016-09-22 |
| 10722355001200 | Detector Color IM | Immunostics Company, Inc | 2016-09-20 |
| 10722355001217 | Detector Color IM | Immunostics Company, Inc | 2016-09-20 |
| 10722355001224 | Detector Monocol | Immunostics Company, Inc | 2016-09-20 |
| 10722355001231 | Detector Monocol | Immunostics Company, Inc | 2016-09-20 |
| 10722355001248 | Detector Lex-IM | Immunostics Company, Inc | 2016-09-20 |
| 10722355001262 | Detector Lex-IM | Immunostics Company, Inc | 2016-09-20 |
| 10722355001279 | Detector Monocol Lex | Immunostics Company, Inc | 2016-09-20 |
| 10722355001286 | Detector Monocol Lex | Immunostics Company, Inc | 2016-09-20 |
| 20885380057417 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-14 |
| 00847865001236 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002455 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865011341 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865011358 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 20885380020312 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-01 |