Product code MIZ— Microbiology
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
- Classification name
- Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
- Device class
- Class 2
- Regulation
- 21 CFR 866.3320
- Advisory panel
- Microbiology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MIZ
FDA has cleared devices under product code MIZ between 1992 and 2011, filed by 2 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
- 2011
- 1992
Top applicants under product code MIZ
Recent clearances under product code MIZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.