21 CFR 866.3300 — Antisera, Fluorescent, All Types, Hemophilus Spp.
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3300
Identification
Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).
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 |
|---|---|---|---|---|
| GRO | Antisera, Fluorescent, All Types, Hemophilus Spp. | 2 | 4 | |
| GRP | Antisera, All Types, H. Influenza | 2 | 6 | |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 2 | 18 | |
| LQH | Dna-Reagents, Legionella | 2 | 2 | |
| MCC | Dna-Probe, Haemophilus Spp. | 2 | 2 | |
| MJH | Legionella, Spp., Elisa | 2 | 10 |
Special Controls
GRO — Antisera, Fluorescent, All Types, Hemophilus 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
GRP — Antisera, All Types, H. Influenza
*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
LHL — Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
*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
LQH — Dna-Reagents, Legionella
*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
MCC — Dna-Probe, Haemophilus 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
MJH — Legionella, Spp., Elisa
*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
