MIDClass II
System, Test, Anticardiolipin Immunological
21 CFR 866.5660 / Immunology
MID is the FDA product code for System, Test, Anticardiolipin Immunological, a class II device type, regulated under 21 CFR 866.5660. As of , FDA records hold 94 510(k) clearances under this code, the most recent dated , and 17 recalls.
Classification record
- Product code
- MID
- Device name
- System, Test, Anticardiolipin Immunological
- Regulation
- 21 CFR 866.5660
- 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
- 94
- Ingested recalls
- 17
Clearances, product code MID
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1991 | 4 |
| 1992 | 8 |
| 1993 | 4 |
| 1994 | 4 |
| 1995 | 11 |
| 1996 | 10 |
| 1997 | 4 |
| 1998 | 6 |
| 1999 | 7 |
| 2000 | 5 |
| 2001 | 5 |
| 2002 | 10 |
| 2003 | 5 |
| 2004 | 1 |
| 2006 | 1 |
| 2010 | 2 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 3 |
| 2024 | 1 |
Applicants with the most clearances
Product code MID| Applicant | Clearances |
|---|---|
| Inova Diagnostics, Inc. | 9 |
| Zeus Scientific LLC | 9 |
| Corgenix, Inc. | 8 |
| Elias U.S.A., Inc. | 7 |
| Immco Diagnostics, Inc. | 5 |
| Immunoprobe, Inc. | 5 |
| The Binding Site | 5 |
| American Laboratory Products Company | 3 |
| Cogent Diagnotics, Ltd. | 3 |
| Diamedix Corp. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this code- AESKU.DIAGNOSTICS GmbH&Co.KG
- American Laboratory Products Company
- Bio-Rad Laboratories Inc.
- Biokit, S.A.
- Corgenix, Inc.
- Diagnostic Automation/ Cortez Diagnostics Inc.
- DRG Instruments GmbH
- DRG International, Inc.
- Hemagen Diagnostics, Inc.
- IMMUNO CONCEPTS, NA, Ltd.
- Immunocentrix Corporation
- Inova Diagnostics, Inc.
FIRST ARTICLE / WEEKLY
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