ClearanceBrief
Panels › Immunology › Product code KTN · Class 2

System, Test, Infectious Mononucleosis

Regulation 866.5640

0510(k)s in 12 months (59 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
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Top companies in KTN

Company510(k)sRecalls
Alere San Diego, Inc.08
Ampcor, Inc.30
Armkel, LLC30
J.S. Medical Assoc.30
Texas Immunology, Inc.30
Gamma Biologicals, Inc.20
Immunostics Co., Inc.20
Instrumentation Laboratory CO20
Organon, Inc.20
Pacific Biotech, Inc.20
DateFirm and productCodeLinked 510(k)
Jun 22, 2016Alere San Diego, Inc.
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whol
Terminated		 KTNK042272
Jun 22, 2016Alere San Diego, Inc.
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in wh
Terminated		 KTNK042272
Jun 22, 2016Alere San Diego, Inc.
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blo
Terminated		 KTNK042272
Jun 22, 2016Alere San Diego, Inc.
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in w
Terminated		 KTNK042272
Jun 22, 2016Alere San Diego, Inc.
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole
Terminated		 KTNK042272
Jun 22, 2016Alere San Diego, Inc.
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood,
Terminated		 KTNK042272
Jun 22, 2016Alere San Diego, Inc.
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and se
Terminated		 KTNK042272
Apr 18, 2013Alere San Diego, Inc.
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infecti
Terminated		 KTNK042272
Apr 22, 2006Remel, Inc.
Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England
Terminated		 KTNK883540

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