21 CFR 866.3660 — Antisera, All Types, Shigella Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3660
Identification
Shigella spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye (immunofluorescent reagents), used in serological tests to identify Shigella spp. from cultured isolates. The identification aids in the diagnosis of shigellosis caused by bacteria belonging to the genus Shigella and provides epidemiological information on this disease. Shigellosis is characterized by abdominal pain, cramps, diarrhea, and fever.
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 |
|---|---|---|---|---|
| GNB | Antisera, All Types, Shigella Spp. | 2 | 41 | |
| GTD | Antisera, Fluorescent, All Globulins, Shigella Spp. | 2 | 0 | |
| LIA | Antigens, All Groups, Shigella Spp. | 2 | 1 | |
| LSN | Dna-Reagents, Shigella Spp. | 2 | 0 |
Special Controls
GNB — Antisera, All Types, Shigella 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
GTD — Antisera, Fluorescent, All Globulins, Shigella 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
LIA — Antigens, All Groups, Shigella 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
LSN — Dna-Reagents, Shigella 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
