Product code DCF
- Device name
- Albumin, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5040
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153560 | Optilite Low Level Albumin Kit | The Binding Site Group , Ltd. | 2016-08-25 |
| K143118 | Human Microalbumin kit for use on SPAPLUS | The Binding Site Group , Ltd. | 2015-05-26 |
| K142346 | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | Beckman Coulter Ireland, Inc. | 2014-10-15 |
| K121045 | HUMAN ALBUMIN CSF KIT | The Binding Site Group , Ltd. | 2013-06-19 |
| K113072 | TINA-QUANT ALBUMIN GEN.2 | Roche Diagnostics Operations | 2012-05-14 |
| K101089 | EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR | Medica Corp. | 2011-07-13 |
| K101203 | TINA-QUANT ALBUMIN GEN 2 | Roche Diagnostics | 2010-09-10 |
| K100853 | COBAS 8000 MODULAR SERIES ANALYZER | Roche Diagnostics Corp. | 2010-09-09 |
| K091486 | K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR | Kamiya Biomedical Co. | 2010-04-29 |
| K082251 | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 | Beckman Coulter, Inc. | 2009-04-08 |
| K061990 | DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL | Dade Behring, Inc. | 2006-09-19 |
| K053553 | NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL | Polymedco, Inc. | 2006-03-09 |
| K051191 | DCL MICROALBUMIN ASSAY, MODEL 252-20 | Diagnostic Chemicals , Ltd. | 2005-07-05 |
| K042643 | VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II | Ortho-Clinical Diagnostics, Inc. | 2004-11-18 |
| K033525 | DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 | Dade Behring, Inc. | 2004-01-12 |
| K972929 | N ANTISERUM TO HUMAN ALBUMIN | Behring Diagnostics, Inc. | 1997-10-20 |
| K964695 | IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT | Beckman Instruments, Inc. | 1997-04-29 |
| K961824 | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN | Roche Diagnostic Systems, Inc. | 1996-07-23 |
| K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN ARRAY PROTEIN SYSTEM | International Enzymes, Inc. | 1995-09-15 |
| K914391 | ALBUMIN TEST RID KIT | The Binding Site, Ltd. | 1991-12-10 |
| K900167 | TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT | Behring Diagnostics, Inc. | 1990-01-22 |
| K896059 | MODIFIED QM300 ALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1989-11-06 |
| K895808 | TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN | Technicon Instruments Corp. | 1989-10-17 |
| K882153 | TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-08-04 |
| K882082 | QM300 ALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-07-08 |
| K881127 | QM300 CALIBRATOR D PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-04-21 |
| K881126 | QM300 ALBUMIN ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-04-06 |
| K875161 | MAT (TM) MICROALBUMIN TEST | Wampole Laboratories | 1988-02-17 |
| K873862 | ALBUMIN IN SERUM | Unipath , Ltd. | 1987-10-20 |
| K873861 | ALBUMIN IN URINE | Unipath , Ltd. | 1987-10-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414320298 | Atellica CH Urine Albumin (UAlb) | Siemens Healthcare Diagnostics Inc. | 2025-08-11 |
| 04050598163300 | Albumin ELISA | Immundiagnostik AG | 2023-06-21 |
| 03610230007235 | Yumizen C1200 Albumin U/CSF | HORIBA ABX SAS | 2020-09-14 |
| 00628063401116 | Microalbumin | SEKISUI DIAGNOSTICS, LLC | 2019-10-02 |
| 06970291985222 | Microalbuminuria Kit (Immunoturbidimetric Method) | Medicalsystem Biotechnology Co., Ltd. | 2019-03-07 |
| 00386100002213 | UALB Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| B24224MABHUE010 | Microalbumin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2018-01-16 |
| 03610230008232 | ABX Pentra Micro ALB 2 Cal | HORIBA ABX SAS | 2017-07-07 |
| 03610230008225 | ABX Pentra Micro ALBUMIN 2 CP | HORIBA ABX SAS | 2017-06-27 |
| 05051700018432 | Optilite Low Level Albumin Kit | THE BINDING SITE GROUP LIMITED | 2017-06-07 |
| 05051700016193 | Human Albumin CSF Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 15099590670108 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| B1761140 | Antiserum to Human Albumin | KENT LABORATORIES INC | 2016-09-24 |
| 05051700010689 | Human Albumin NL BINDARID™ Radial Immunodiffusion | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 15099590010645 | AU | BECKMAN COULTER IRELAND INC. | 2016-09-24 |
| 05051700017916 | Optilite Albumin Kit | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 05051700017923 | Human Microalbumin Kit for use on SPAPLUS | THE BINDING SITE GROUP LIMITED | 2016-09-24 |
| 00842768005312 | Dimension® Flex® reagent cartridge MALB | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768006098 | DImension Vista® sALB Flex® reagent cartridgeSpecialty Albumin | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 15099590020422 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 04015630924899 | Tinaquant Albumin Gen2 | Roche Diagnostics GmbH | 2016-09-20 |
| 03610230005774 | ABX PENTRA MICRO-ALB CAL | HORIBA ABX SAS | 2016-09-05 |
| 15099590225339 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590221201 | IMMAGE | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750003754 | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-24 |
| 10758750003723 | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-24 |
| 10758750003716 | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-24 |
| 10758750003679 | ORTHO | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-24 |
| 03610230005767 | ABX PENTRA MICRO ALBUMIN CP | HORIBA ABX SAS | 2016-08-16 |
| 10758750006892 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-10 |