Product code LIR— Microbiology
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
- Classification name
- Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
- Device class
- Class 2
- Regulation
- 21 CFR 866.3390
- Advisory panel
- Microbiology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code LIR
FDA has cleared devices under product code LIR between 1988 and 2003, 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
- 2003
- 1988
Top applicants under product code LIR
Recent clearances under product code LIR
Data sourced from openFDA. This site is unofficial and independent of the FDA.