Product code LEH
- Device name
- Radioimmunoassay, Vancomycin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3950
- Review panel
- TX
- 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 |
|---|---|---|---|
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023-08-08 |
| K160202 | Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) | Siemens Healthcare Diagnostics, Inc. | 2016-04-27 |
| K152245 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics Operations (Rdo) | 2016-01-08 |
| K123947 | ARCHITECT IVANCOMYCIN | Biokit, S.A. | 2013-08-29 |
| K072036 | ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 | Biokit, S.A. | 2008-03-19 |
| K063045 | IMMULITE 2000, IMMULITE 2500 VANCOMYCIN | Diagnostic Products Corp. | 2006-12-05 |
| K060586 | ENZYME IMMUNOASSAY, VANCOMYCIN | Roche Diagnostics Corp. | 2006-05-11 |
| K050419 | QMS VANCOMYCIN | Seradyn, Inc. | 2005-04-01 |
| K043386 | VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III | Ortho-Clinical Diagnostics, Inc. | 2005-02-07 |
| K032811 | CEDIA VANCOMYCIN ASSAY | Microgenics Corp. | 2003-11-24 |
| K020692 | EMIT 2000 VANCOMYCIN ASSAY | Dade Behring, Inc. | 2002-05-10 |
| K013076 | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR | Beckman Coulter, Inc. | 2001-12-12 |
| K983280 | VANCOMYCIN EIA ASSAY | Diagnostic Reagents, Inc. | 1998-11-06 |
| K964587 | VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM | Bayer Corp. | 1997-01-13 |
| K963267 | VANCOMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 |
| K955851 | AXSYM VANCOMYCIN II | Abbott Laboratories | 1996-05-09 |
| K955716 | VANCOMYCIN FPIA REAGENT SET | Sigma Diagnostics, Inc. | 1996-02-16 |
| K953528 | ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN | Roche Diagnostic Systems, Inc. | 1995-09-12 |
| K951059 | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-06-19 |
| K945125 | DUPONT ACA VANCOMYCIN (VANC) METHOD | The DU Pont Co. | 1995-03-10 |
| K940595 | AXSYM VANCOMYCIN | Abbott Laboratories | 1994-06-21 |
| K924957 | OPUS(R) VANCOMYCIN | Pb Diagnostic Systems, Inc. | 1992-12-11 |
| K901759 | COBAS-FP REAGENTS FOR VANCOMYCIN | Roche Diagnostic Systems, Inc. | 1990-05-02 |
| K900708 | MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-19 |
| K892900 | ACA VANCOMYCIN (VANC) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1989-05-22 |
| K881040 | EMIT VANCOMYCIN ASSAY | Syva Co. | 1988-04-19 |
| K874438 | STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1988-01-21 |
| K872579 | INNOFLUOR VANCOMYCIN REAGENT SET | Innotron of Oregon, Inc. | 1987-08-17 |
| K822308 | VANCOMYCIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-08-16 |
| K821136 | TDX TM STREPTOMYCIN | Abbott Laboratories | 1982-05-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336157800 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics GmbH | 2020-03-05 |
| 07613336121627 | ONLINE TDM Vancomycin Gen.3 | Roche Diagnostics GmbH | 2020-03-05 |
| 00380740156237 | ARCHITECT | Abbott GmbH | 2020-03-03 |
| 00380740135348 | Alinity | ABBOTT LABORATORIES | 2018-11-07 |
| 00630414596020 | Atellica CH Vanc | Siemens Healthcare Diagnostics Inc. | 2017-12-19 |
| 04015630934416 | ONLINE TDM Vancomyin Gen.3 | Roche Diagnostics GmbH | 2016-10-13 |
| 04015630934447 | ONLINE TDM Vancomyin Gen.3 | Roche Diagnostics GmbH | 2016-10-13 |
| 00630414561967 | ADVIA® Chemistry VANC_2 Vancomycin_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414443096 | ADVIA Centaur® VANC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414203928 | ADVIA Centaur® VANC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414126111 | ADVIA Centaur® VANC MCM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001109 | Syva® Emit® 2000 Vancomycin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005763 | Dimension® Flex® reagent cartridge VANC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015533 | Dimension Vista® Flex® reagent cartridge VANC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023323 | Emit® 2000 Vancomycin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883011182 | QMS Vancomycin Immunoassay | Microgenics Corporation | 2016-09-24 |
| 00630414121451 | ADVIA Centaur® Vancomycin Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414121444 | ADVIA Centaur® Systems, ACS:180® Systems VANC Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883012837 | QMS Vancomycin Immunoassay | Microgenics Corporation | 2016-09-22 |
| 04015630915996 | Vancomycin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630997978 | Vancomycin ONLINE TDM Vancomycin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630998920 | Vancomycin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630999392 | Vancomycin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630997961 | Vancomycin ONLINE TDM Vancomycin | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883011243 | QMS Vancomycin Immunoassay | Microgenics Corporation | 2016-08-26 |
| 10758750006731 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-26 |
| 15099590223342 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740001711 | ARCHITECT | Abbott GmbH | 2016-06-06 |
| 00380740009847 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00380740105327 | ARCHITECT | Abbott GmbH | 2016-06-06 |