21 CFR 866.3350 — Antisera, All Fluorescent, Leptospira Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3350
Identification
Leptospira spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Leptospira spp. in serum or identify Leptospira spp. from cultured isolates derived from clinical specimens. Additionally, some of these antisera are conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify Leptospira spp. directly from clinical specimens. The identification aids in the diagnosis of leptospirosis caused by bacteria belonging to the genus Leptospira and provides epidemiological information on this disease. Leptospira infections range from mild fever-producing illnesses to severe liver and kidney involvement producing hemorrhage and dysfunction of these organs.
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 |
|---|---|---|---|---|
| GRW | Antisera, All Fluorescent, Leptospira Spp. | 2 | 0 | |
| GRX | Antisera, All Leptospira Spp. | 2 | 0 | |
| GRY | Antigens, All, Leptospira Spp. | 2 | 2 |
Special Controls
GRW — Antisera, All Fluorescent, Leptospira Spp.
*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
GRX — Antisera, All Leptospira Spp.
*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
GRY — Antigens, All, Leptospira Spp.
*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
