Product code DAB— Immunology
FIAX HAPTOGLOBIN TEST KIT
- Classification name
- Haptoglobin, Fitc, Antigen, Antiserum, Control
- Device class
- Class 2
- Regulation
- 21 CFR 866.5460
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code DAB
FDA has cleared devices under product code DAB between 1978 and 1991, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1991
- 1984
- 1978
Top applicants under product code DAB
Recent clearances under product code DAB
Data sourced from openFDA. This site is unofficial and independent of the FDA.