21 CFR 866.3415 — Antisera, Fluorescent, Pseudomonas Pseudomallei
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3415
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GSR | Antisera, Fluorescent, Pseudomonas Pseudomallei | 2 | 0 | |
| GSS | Antisera, Fluorescent, Pseudomonas Aeruginosa | 2 | 1 | |
| GST | Antiserum, Pseudomonas Pseudomallei | 2 | 0 |
Special Controls
GSR — Antisera, Fluorescent, Pseudomonas Pseudomallei
*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.
eCFR
GSS — Antisera, Fluorescent, Pseudomonas Aeruginosa
*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.
eCFR
GST — Antiserum, Pseudomonas Pseudomallei
*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.
eCFR
