OZA · Class III — High Risk (PMA approval required, life-sustaining) · Microbiology · 21 CFR 866.3110
Classification
FDA Product Code
OZA
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
21 CFR 866.3110
Review panel
MI
Medical specialty
Microbiology
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Intended for use in the qualitative detection of urease associated with h. Pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of h. Pylori infection in adults and pediatric patients. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy.