GSS · Antisera, Fluorescent, Pseudomonas Aeruginosa
Microbiology · 21 CFR 866.3415 · Class 2
Overview
| Product Code | GSS |
|---|---|
| Device Name | Antisera, Fluorescent, Pseudomonas Aeruginosa |
| Regulation | 21 CFR 866.3415 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Pseudomonas spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used to identify Pseudomonas spp. from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Pseudomonas. Pseudomonas aeruginosa is a major cause of hospital-acquired infections, and has been associated with urinary tract infections, eye infections, burn and wound infections, blood poisoning, abscesses, and meningitis (inflammation of brain membranes). Pseudomonas pseudomallei causes melioidosis, a chronic pneumonia.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921461 | TURKEL THORACENTESIS NEEDLE | Symbiosis Corp. | Jul 30, 1992 | SESE |
Top Applicants
- Symbiosis Corp. — 1 clearance
