Product code LKQ
- Device name
- Antibody Igm,If, Cytomegalovirus Virus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3175
- 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 |
|---|---|---|---|
| K100433 | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, | Siemens Healthcare Diagnostics | 2010-05-13 |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | Boston Biomedica, Inc. | 1997-08-22 |
| K933549 | VIDAS CMV IGM ASSAY | Biomerieux Vitek, Inc. | 1994-08-02 |
| K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA | Baxter Diagnostics, Inc. | 1993-04-08 |
| K914789 | ELISA CMV IGM | Sclavo, Inc. | 1992-03-04 |
| K913080 | OPUS(R) ANTI CMV-M | Pb Diagnostics, Inc. | 1991-10-28 |
| K900743 | CMV-IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1990-04-26 |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-25 |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 |
| K872881 | ABBOTT CMV-M EIA KIT | Abbott Laboratories | 1988-05-13 |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Clinical Sciences, Inc. | 1988-01-11 |
| K871832 | CMV IGM MICROASSAY | Diamedix Corp. | 1987-08-07 |
| K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | Whittaker Bioproducts, Inc. | 1987-04-14 |
| K861363 | ENZYGNOST ANTI-CMV IGM TEST | Behring Diagnostics, Inc. | 1986-07-21 |
| K860450 | THE CMV-IGM TEST | Microbiological Research Corp. | 1986-05-13 |
| K853889 | CORDIA CMV-M | Cordis Corp. | 1986-04-21 |
| K854839 | CYTOMEGELISA M TEST KIT | Whittaker Bioproducts, Inc. | 1986-02-04 |
| K831711 | CMV IGM TEST | Gull Laboratories, Inc. | 1983-10-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03610520150269 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 03610520992715 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 03610521167488 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 00816784020444 | ACCURUN® | Lgc Clinical Diagnostics, Inc. | 2016-09-24 |
| 00630414985718 | IMMULITE®/IMMULITE® 1000 Systems CMV IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00630414985725 | IMMULITE® 2000 Systems CMM CMV IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2016-09-24 |
| 00847865001175 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865003186 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865011006 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012577 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865003179 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 03573026156848 | VIDAS® CMV IgM | BIOMERIEUX SA | 2016-08-31 |