Panels › Microbiology › Product code LJO · Class 2
Antigen, Iha, Cytomegalovirus
Regulation 866.3175
0510(k)s in 12 months (12 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LJO
| Company | 510(k)s | Recalls |
|---|---|---|
| Immucor, Inc. | 3 | 0 |
| Akers Research Corp. | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Cetus Corp. | 1 | 0 |
| Diamedix Corp. | 1 | 0 |
| Digene Corp. | 1 | 0 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 0 |
| Hillcrest Biologicals | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Sienna Biotech, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2021 | K203612 | Capture-CMV Immucor, Inc. | LJO |
| Feb 4, 2019 | K183571 | Capture-CMV Immucor, Inc. | LJO |
| Aug 7, 2000 | K001767 | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM Diamedix Corp. | LJO |
| Sep 29, 1998 | K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY Digene Corp. | LJO |
| May 1, 1998 | K974456 | CMVGEN Instrumentation Laboratory CO | LJO |
| Jul 24, 1996 | K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY E.I. Dupont DE Nemours & Co., Inc. | LJO |
| Jul 10, 1996 | K955799 | COPALIS CMV TOTAL ANTIBODY ASSAY Sienna Biotech, Inc. | LJO |
| Jul 27, 1992 | K920222 | HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS Akers Research Corp. | LJO |
| Mar 20, 1991 | K910003 | CYTOMEGALOVIRUS ANTIBODY SCREEN Immucor, Inc. | LJO |
| Sep 16, 1985 | K852494 | CMV-IHA Hillcrest Biologicals | LJO |
| Sep 7, 1984 | K841520 | CMV LATEX AGGLUTINATION TEST KIT Bd Becton Dickinson Vacutainer Systems Preanalytic | LJO |
| Feb 15, 1983 | K822965 | CETUS CMV IHA Cetus Corp. | LJO |
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