System, Test, Infectious Mononucleosis
FDA product code KTN · Class II (moderate risk) · 21 CFR 866.5640 · Immunology
59510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Ampcor, Inc. 3
- Texas Immunology, Inc. 3
- Armkel, LLC 3
- J.S. Medical Assoc. 3
- Immunostics Inc., 2
- Unipath , Ltd. 2
- Pacific Biotech, Inc. 2
- Quidel Corp. 2
- Gamma Biologicals, Inc. 2
- Instrumentation Laboratory CO 2
- Organon, Inc. 2
- American Dade 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Preco, Inc. 1
- Cooper Biomedical, Inc. 1
- SEKISUI Diagnostics, LLC 1
- Tago, Inc. 1
- Sclavo, Inc. 1
- Biokit USA, Inc. 1
- Cordis Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181436 | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II…KTN · Special | SEKISUI Diagnostics, LLC | 06/22/2018SE |
| K042272 | Acon Mononucleosis Rapid Test Strip (Whole Blood/Serum/Plasma)KTN · Traditional | ACON Laboratories, Inc. | 02/28/2005SE |
| K030215 | Biorapid MononucleosisKTN · Traditional | Instrumentation Laboratory CO | 02/24/2003SE |
| K012901 | Color-MonogenKTN · Traditional | Instrumentation Laboratory CO | 09/27/2001SE |
| K982634 | Dryspot Infectious Mononucleosis KitKTN · Traditional | Oxoid , Ltd. | 01/28/1999SE |
| K981946 | Clearview ImKTN · Traditional | Unipath , Ltd. | 12/10/1998SE |
| K972457 | Monocol/Lex-Im TestKTN · Traditional | Immunostics Inc., | 12/01/1997SE |
| K972231 | Osom Mono Test 143KTN · Traditional | Wyntek Diagnostics, Inc. | 08/26/1997SE |
| K963425 | Genzyme Diagnostics Contrast MonoKTN · Traditional | Genzyme Diagnostics | 02/25/1997SE |
| K961024 | Biosign Mono-Plus Wb,Biosign Mono Wb,Mono-Plus Wb,Accusign Mono WBKTN · Traditional | Princeton BioMeditech Corp. | 02/04/1997SE |
| K961550 | Qualitrol Mono Control Serum SetKTN · Traditional | Consolidated Technologies, Inc. | 09/24/1996SE |
| K930778 | Immunocard MonoKTN · Traditional | Meridian Diagnostics, Inc. | 12/27/1993SE |
| K932688 | Eye Spot Im TestKTN · Traditional | J.S. Medical Assoc. | 09/08/1993SE |
| K932551 | Accutex Im Latex TestKTN · Traditional | J.S. Medical Assoc. | 08/09/1993SE |
| K925183 | Biosign(Tm) Mono-Infect Mono Hetero Antibody TestKTN · Traditional | Princeton Biomedix | 02/23/1993SE |
| K924037 | Accutex Im RBC TestKTN · Traditional | J.S. Medical Assoc. | 11/02/1992SE |
| K923767 | Pulse Im Red Cell TestKTN · Traditional | Pulse Scientific, Inc. | 10/16/1992SE |
| K922726 | Tech Simple Infectious Mononucleosis Serum ControlKTN · Traditional | Simplicity Diagnostics, Inc. | 10/05/1992SE |
| K922297 | Infectious Mononucleosis Qik-Dot Im Dry Card TestKTN · Traditional | Ampcor, Inc. | 07/14/1992SE |
| K922296 | Imfectious Mononucleosis Im Liquid Card TestKTN · Traditional | Ampcor, Inc. | 07/14/1992SE |
| K920221 | Healthtest Infectious Mononucleosis AssayKTN · Traditional | Akers Research Corp. | 03/13/1992SE |
| K902510 | Cards O.S. MonoKTN · Traditional | Pacific Biotech, Inc. | 07/16/1990SE |
| K902541 | Mono-Lex System: Infectious Mononucleosis LatexKTN · Traditional | Trinity Laboratories, Inc. | 06/28/1990SE |
| K900625 | Mono-Plus Positive and Negative Control SetKTN · Traditional | Armkel, LLC | 02/26/1990SE |
| K896926 | Directigen 1-2-3 Infectious Mononucleosis ControlsKTN · Traditional | Quidel Corp. | 01/26/1990SE |
| K895891 | Detectadot System 2000 Heterophile TestKTN · Traditional | Gull Laboratories, Inc. | 10/31/1989SE |
| K895765 | Leeco Preview(R) Ebv (Eia)KTN · Traditional | Leeco Diagnostics, Inc. | 10/31/1989SE |
| K894975 | Immunodot Infectious Mononucleosis TestKTN · Traditional | General Biometrics, Inc. | 09/13/1989SE |
| K894793 | MonodexKTN · Traditional | Cenogenics Corp. | 08/21/1989SE |
| K893737 | Directigen 1-2-3 Infectious Mononucleosis TestKTN · Traditional | Quidel Corp. | 06/16/1989SE |
| K890991 | Mono-Cube(Tm)KTN · Traditional | Difco Laboratories, Inc. | 03/16/1989SE |
| K890041 | V-Trend Target Im TestKTN · Traditional | Texas Immunology, Inc. | 01/23/1989SE |
| K883709 | Modification of Mono-Plus(Tm)KTN · Traditional | Armkel, LLC | 12/20/1988SE |
| K884007 | Cards(Tm) MonoKTN · Traditional | Pacific Biotech, Inc. | 11/18/1988SE |
| K883540 | Oxoid Infectious Mononucleosis KitKTN · Traditional | Unipath , Ltd. | 10/19/1988SE |
| K883004 | Mono-Plus(Tm)KTN · Traditional | Wampole Laboratories | 08/04/1988SE |
| K881247 | Mono-PhileKTN · Traditional | Bio Diagnostic Systems, Inc. | 04/07/1988SE |
| K880399 | V-Trend Im Dry-Spot TestKTN · Traditional | Texas Immunology, Inc. | 02/17/1988SE |
| K880148 | Infectious Mononucleosis (Im) Card & Liquid TestKTN · Traditional | Ampcor, Inc. | 02/10/1988SE |
| K874678 | I.M.N. LatexKTN · Traditional | Biokit USA, Inc. | 12/14/1987SE |
| K873297 | Differential I.M. Screening TestKTN · Traditional | Sclavo, Inc. | 12/14/1987SE |
| K872032 | Ventrescreen (TM) MonoKTN · Traditional | Ventrex Laboratories, Inc. | 06/29/1987SE |
| K864207 | Disposable Test Cards/Gamma Slide Test Infect MonoKTN · Traditional | Gamma Biologicals, Inc. | 12/03/1986SE |
| K862008 | Mono-Latex (TM) Slide TestKTN · Traditional | Armkel, LLC | 07/03/1986SE |
| K861452 | Monostar System: Im Latex TestKTN · Traditional | U.S. Health Resources Corp. | 05/13/1986SE |
| K861016 | Gamma Slide Test for Infectious MononucleosisKTN · Traditional | Gamma Biologicals, Inc. | 04/18/1986SE |
| K853144 | Card Three Im Test Item #2035, Card One Im #2036KTN · Traditional | Preco, Inc. | 10/16/1985SE |
| K853105 | Immuno-ImKTN · Traditional | Immunostics Co., Inc. | 09/03/1985SE |
| K853388 | Monosticon Uni-DotKTN · Traditional | Organon, Inc. | 08/22/1985SE |
| K844289 | Series I/S InfectionsKTN · Traditional | American Dade | 11/19/1984SE |
| K841863 | Mono-TecKTN · Traditional | Medilab Corp. | 06/13/1984SE |
| K840822 | Leap Mono Test KitKTN · Traditional | Cooper Biomedical, Inc. | 04/05/1984SE |
| K834345 | Im-CheckKTN · Traditional | Diagnostic Technology, Inc. | 02/10/1984SE |
| K830531 | Mono Screening TestKTN · Traditional | Tago, Inc. | 03/17/1983SE |
| K821386 | Sero/Tex Mono TestKTN · Traditional | Texas Immunology, Inc. | 07/02/1982SE |
| K812540 | Cordia ImKTN · Traditional | Cordis Corp. | 09/24/1981SE |
| K791455 | Agglutinotest-Infectious MononucleosisKTN · Traditional | Volu Sol Medical Industries | 12/31/1979SE |
| K771397 | Monosticon TestKTN · Traditional | Organon, Inc. | 08/22/1977SE |
| K760040 | Test, Mono., Card (Macro-Vue)KTN · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/03/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2271-2016 Class III | Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-2270-2016 Class III | Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-2269-2016 Class III | Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-2268-2016 Class III | Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-2267-2016 Class III | Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-2266-2016 Class III | Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-2265-2016 Class III | Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404.…The Positive Control information referencing human plasma as the antibody material described in the product… | Alere San Diego, Inc. | 06/22/2016Terminated |
| Z-1148-2013 Class III | IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog…Alere San Diego is recalling the Clearview Mononucleosis Cassette because the positive control included in… | Alere San Diego, Inc. | 02/26/2013Terminated |