21 CFR 866.3550 — Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3550
Identification
Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Salmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genus Salmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.
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 |
|---|---|---|---|---|
| GNC | Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. | 2 | 60 | |
| GOO | Antisera, Fluorescent, All Globulins, Salmonella Spp. | 2 | 0 | |
| GRL | Antigens, All Groups, Salmonella Spp. | 2 | 2 | |
| GRM | Antisera, All Groups, Salmonella Spp. | 2 | 69 | |
| LSM | Dna-Reagents, Salmonella Spp. | 2 | 0 |
Special Controls
GNC — Antigens, Febrile, Slide And Tube, All Groups, Salmonella 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
GOO — Antisera, Fluorescent, All Globulins, Salmonella 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
GRL — Antigens, All Groups, Salmonella 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
GRM — Antisera, All Groups, Salmonella 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
LSM — Dna-Reagents, Salmonella 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
