21 CFR 866.3165 — Antisera, Latex Agglutination, Cryptococcus Neoformans
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3165
Identification
Cryptococcus neoformans serological reagents are devices that consist of antigens used in serological tests to identify antibodies to Cryptococcus neoformans in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) and are used to identify Cryptococcus neoformans directly from clinical specimens or from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of cryptococcosis and provides epidemiological information on this type of disease. Cryptococcosis infections are found most often as chronic meningitis (inflammation of brain membranes) and, if not treated, are usually fatal.
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 |
|---|---|---|---|---|
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 2 | 10 | |
| GME | Antisera, Fluorescent, Cryptococcus Neoformans | 2 | 0 | |
| JWK | Antigen, Positive Control, Cryptococcus Neoformans | 2 | 1 | |
| LHK | Antigen, Id, Candida Albicans | 2 | 4 | |
| LRF | Candida Spp., Direct Antigen, Id | 2 | 3 | |
| LSG | Candida Species, Antibody Detection | 2 | 0 | |
| MDE | Dna-Probe, Reagents, Cryptococcal | 2 | 1 | |
| MDU | Antigen, Elisa, Cryptococcus | 2 | 2 |
Special Controls
GMD — Antisera, Latex Agglutination, Cryptococcus Neoformans
*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
GME — Antisera, Fluorescent, Cryptococcus Neoformans
*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
JWK — Antigen, Positive Control, Cryptococcus Neoformans
*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
LHK — Antigen, Id, Candida Albicans
*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
LRF — Candida Spp., Direct Antigen, Id
*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
LSG — Candida Species, Antibody Detection
*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
MDE — Dna-Probe, Reagents, Cryptococcal
*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
MDU — Antigen, Elisa, Cryptococcus
*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
