Enzyme Immunoassay, Digitoxin
FDA product code LFM · Class II (moderate risk) · 21 CFR 862.3300 · Clinical Toxicology
20510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Diagnostic Products Corp. 4
- Abbott Laboratories 3
- Dade Behring, Inc. 2
- American Dade 1
- E.I. Dupont DE Nemours & Co., Inc. 1
- Microgenics Corp. 1
- Tudor Laboratories, Inc. 1
- Intl. Bioclinical, Inc. 1
- Sigma Diagnostics, Inc. 1
- Syva Co. 1
- Eastman Kodak Company 1
- Bayer Corp. 1
- Chiron Diagnostics Corp. 1
- Randox Laboratories, Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K062024 | Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…LFM · Special | Dade Behring, Inc. | 07/28/2006SE |
| K012112 | Randox DigitoxinLFM · Traditional | Randox Laboratories, Ltd. | 01/11/2002SE |
| K990251 | DGTX Flex Reagent Cartridge, Model DF36LFM · Traditional | Dade Behring, Inc. | 03/31/1999SE |
| K970546 | Acs DigitoxinLFM · Traditional | Chiron Diagnostics Corp. | 07/14/1997SE |
| K963158 | Abbott Axsym Digitoxin (Modify)LFM · Traditional | Abbott Laboratories | 09/10/1996SE |
| K954420 | Axsym DigitoxinLFM · Traditional | Abbott Laboratories | 12/29/1995SE |
| K951631 | Digoxin Assay for the Tecchnicon Ra/Opera Systems In-Vitro Diagnostic SystemsLFM · Traditional | Bayer Corp. | 06/09/1995SE |
| K943235 | Immulite DigitoxinLFM · Traditional | Diagnostic Products Corp. | 10/27/1994SE |
| K942610 | Kodak Extachem Clinical Chemistry Slide Digoxin (DGXN)LFM · Traditional | Eastman Kodak Company | 10/20/1994SE |
| K942619 | Emit 2000 Digoxin Assay/CalibratorsLFM · Traditional | Syva Co. | 09/20/1994SE |
| K915465 | Digitoxin Fpia Reagent SetLFM · Traditional | Sigma Diagnostics, Inc. | 01/27/1992SE |
| K913187 | Innofluor(Tm) Digitoxin Reagent SetLFM · Traditional | Intl. Bioclinical, Inc. | 09/23/1991SE |
| K913240 | Digitoxin (Fpia) KitLFM · Traditional | Tudor Laboratories, Inc. | 09/06/1991SE |
| K900013 | Milenia (TM) DigitoxinLFM · Traditional | Diagnostic Products Corp. | 03/09/1990SE |
| K896021 | Cedia Digitoxin AssayLFM · Traditional | Microgenics Corp. | 11/08/1989SE |
| K891094 | Aca(R) Digitoxin (DGTX) MethodLFM · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 04/26/1989SE |
| K862067 | Stratus Digitoxin Fluorometric Enzyme ImmunoassayLFM · Traditional | American Dade | 06/16/1986SE |
| K842280 | TDX DigitoxinLFM · Traditional | Abbott Laboratories | 08/16/1984SE |
| K842578 | Sopheia/Mp Digitoxin Eia KitLFM · Traditional | Diagnostic Products Corp. | 08/12/1984SE |
| K830035 | Sopheia Digitoxin Eia Kit & ComponentsLFM · Traditional | Diagnostic Products Corp. | 01/28/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0902-2025 Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN…Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause… | Quidel Ortho | 12/05/2024Open, Classified |
| Z-0901-2025 Class II | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN…Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause… | Quidel Ortho | 12/05/2024Open, Classified |
| Z-0310-2014 Class II | VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386…Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product… | Ortho-Clinical Diagnostics | 06/12/2013Terminated |
| Z-0510-2013 Class II | Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | Siemens Healthcare Diagnostics, Inc | 11/14/2012Terminated |
| Z-2211-2012 Class II | VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box…Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and… | Ortho-Clinical Diagnostics | 06/28/2012Terminated |