Device |
test, urea adult and pediatric (breath), |
Regulation Description |
Campylobacter fetus serological reagents. |
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. |
Physical State |
Human Breath |
Technical Method |
System utilizes an Infrared Spectrophotometer |
Target Area |
Stomach, esophagogastroduodenoscopy |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | OZA |
Premarket Review |
Division of Microbiology Devices
(DMD)
Division of Microbiology Devices
(DMD)
|
Submission Type |
PMA
|
Regulation Number |
866.3110
|
Device Class |
3
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |