Bromcresol Purple Dye-Binding, Albumin
FDA product code CJW · Class II (moderate risk) · 21 CFR 862.1035 · Clinical Chemistry
18510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Abbott Laboratories 3
- Em Diagnostic Systems, Inc. 2
- Quantimetrix Corp. 1
- Sandare Chemical Co., Inc. 1
- Wako Chemicals USA, Inc. 1
- Boehringer Mannheim Corp. 1
- Sigma Diagnostics, Inc. 1
- Biochemical Trade, Inc. 1
- Abbott Mfg., Inc. 1
- A.P. Total Care, Inc. 1
- Randox Laboratories, Ltd. 1
- Intersect Systems, Inc. 1
- Siemens Healthcare Diagnostics, Inc. 1
- SENTINEL CH. SpA 1
- Abbott Ireland Diagnostics Division 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203530 | Albumin BCP2CJW · Traditional | Abbott Ireland Diagnostics Division | 03/18/2022SE |
| K193001 | Albumin BCPCJW · Traditional | SENTINEL CH. SpA | 12/19/2019SE |
| K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP CalibratorCJW · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/16/2013SE |
| K021636 | Albumin ReagentCJW · Traditional | Intersect Systems, Inc. | 07/17/2002SE |
| K000483 | Randox AlbuminCJW · Traditional | Randox Laboratories, Ltd. | 03/31/2000SE |
| K990978 | Albumin BCG, Model Al 103-01CJW · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K981814 | AlbpCJW · Traditional | Abbott Laboratories | 07/22/1998SE |
| K981457 | AlbpCJW · Traditional | Abbott Mfg., Inc. | 05/27/1998SE |
| K913025 | Abbott Quickstart Albumin BCP (ALBP)#5A16CJW · Traditional | Em Diagnostic Systems, Inc. | 10/09/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | Biochemical Trade, Inc. | 02/26/1991SE |
| K863226 | Albumin (BCP)CJW · Traditional | Sigma Diagnostics, Inc. | 09/17/1986SE |
| K863004 | Emds(Tm) Albumin Testpacks, #67652/95CJW · Traditional | Em Diagnostic Systems, Inc. | 09/16/1986SE |
| K862138 | Vision AlbuminCJW · Traditional | Abbott Laboratories | 06/17/1986SE |
| K860423 | A-Gent Liquid AlbuminCJW · Traditional | Abbott Laboratories | 03/17/1986SE |
| K844426 | Albumin BCPCJW · Traditional | Boehringer Mannheim Corp. | 01/07/1985SE |
| K842847 | Wako Automated Reagents for Hitachi 705CJW · Traditional | Wako Chemicals USA, Inc. | 12/11/1984SE |
| K832632 | Albumin Procedure BCPCJW · Traditional | Sandare Chemical Co., Inc. | 09/12/1983SE |
| K830934 | Quantimetrix Bromeresol Purple AlbuminCJW · Traditional | Quantimetrix Corp. | 04/18/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1194-2019 Class II | Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative…The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated… | Roche Diagnostics Corporation | 03/18/2019Terminated |