Product code MIY— Microbiology
PREMIER COCCIDIOIDES
- Classification name
- Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
- Device class
- Class 2
- Regulation
- 21 CFR 866.3135
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code MIY
FDA has cleared device under product code MIY, all in 1992, filed by 1 applicant company. 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.
Top applicants under product code MIY
Recent clearances under product code MIY
Data sourced from openFDA. This site is unofficial and independent of the FDA.