DDGClass II
Transferrin, Antigen, Antiserum, Control
21 CFR 866.5880 / Immunology
DDG is the FDA product code for Transferrin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5880. As of , FDA records hold 48 510(k) clearances under this code, the most recent dated , and 6 recalls.
Classification record
- Product code
- DDG
- Device name
- Transferrin, Antigen, Antiserum, Control
- Regulation
- 21 CFR 866.5880
- Device class
- Class II
- Review panel
- Immunology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 48
- Ingested recalls
- 6
Clearances, product code DDG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1981 | 3 |
| 1983 | 1 |
| 1985 | 2 |
| 1986 | 1 |
| 1987 | 4 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 2 |
| 1996 | 1 |
| 1997 | 4 |
| 1998 | 2 |
| 1999 | 3 |
| 2000 | 1 |
| 2001 | 5 |
| 2004 | 1 |
| 2006 | 1 |
| 2007 | 4 |
| 2008 | 2 |
| 2013 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code DDG| Applicant | Clearances |
|---|---|
| Siemens Healthcare Diagnostics Inc. | 8 |
| Beckman Instruments, Inc. | 4 |
| Boehringer Mannheim Corp. | 3 |
| Roche Diagnostics GmbH | 3 |
| Abbott Medical | 2 |
| The Binding Site | 2 |
| Applications Lab | 1 |
| Atlantic Antibodies | 1 |
| Behring Diagnostics, Inc. | 1 |
| Biocell Laboratories, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.