Haptoglobin, Antigen, Antiserum, Control
FDA product code DAD · Class II (moderate risk) · 21 CFR 866.5460 · Immunology
18510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Unipath , Ltd. 1
- Kamiya Biomedical Co. 1
- Boehringer Mannheim Corp. 1
- Crestat Diagnostics, Inc. 1
- Beckman Instruments, Inc. 1
- Behring Diagnostics, Inc. 1
- Instrumentation Laboratory CO 1
- Reagents Applications, Inc. 1
- Atlantic Antibodies 1
- Oxford Laboratories, Inc. 1
- Kallestad Diag, A Div. of Erbamont, Inc. 1
- Cooper Biomedical, Inc. 1
- Applications Lab 1
- Tago, Inc. 1
- Kent Laboratories, Inc. 1
- Dako Corp. 1
- J.T. Baker Chemical Co. 1
- Kallestad Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993480 | K-Assay HaptoglobinDAD · Traditional | Kamiya Biomedical Co. | 11/24/1999SE |
| K972639 | Tina-Quant HaptoglobinDAD · Traditional | Boehringer Mannheim Corp. | 01/09/1998SE |
| K964301 | N-Assay Tia Multi V-NlDAD · Traditional | Crestat Diagnostics, Inc. | 07/14/1997SE |
| K963286 | Immage Immunochemistry System Haptoglobin (HPT) ReagentDAD · Traditional | Beckman Instruments, Inc. | 10/07/1996SE |
| K952593 | N/T Protein Control Sy/L, M and HDAD · Traditional | Behring Diagnostics, Inc. | 07/17/1995SE |
| K915829 | Il Test(Tm) Haptoglobin (HPT)DAD · Traditional | Instrumentation Laboratory CO | 07/29/1992SE |
| K911898 | Raichem(Tm) Spia(Tm) Haptoglobin ReagentDAD · Traditional | Reagents Applications, Inc. | 05/08/1991SE |
| K890562 | Spq(Tm) Antibody Reagent Set II for HPTDAD · Traditional | Atlantic Antibodies | 02/22/1989SE |
| K873866 | HaptoglobinDAD · Traditional | Unipath , Ltd. | 10/20/1987SE |
| K872717 | QM300 Haptoglobin Antibody PackDAD · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/21/1987SE |
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | Cooper Biomedical, Inc. | 02/13/1987SE |
| K850584 | SPQ Test System for HaptoglobinDAD · Traditional | Applications Lab | 03/05/1985SE |
| K840404 | Diffu-Gen Haptoglobin Radial ImmunoDAD · Traditional | Tago, Inc. | 03/09/1984SE |
| K831957 | Determ. Size 72 Radial Human HaptoglobDAD · Traditional | Kent Laboratories, Inc. | 07/18/1983SE |
| K812494 | Immunogl. Frct. of Rabbit Antiser.-HaptoDAD · Traditional | Dako Corp. | 09/23/1981SE |
| K801433 | Haptoglobin Nephelometric AssayDAD · Traditional | J.T. Baker Chemical Co. | 07/08/1980SE |
| K772245 | Haptoglobin Nephelometric AssayDAD · Traditional | Kallestad Laboratories, Inc. | 12/22/1977SE |
| K760144 | Serum, Haptoglobin Goat Anti-Human AcidDAD · Traditional | Oxford Laboratories, Inc. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1993-2019 Class II | The,K -ASSAY HP assay is intended for the quantitative determination of human…An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU… | Abbott Laboratories, Inc | 05/16/2018Terminated |