21 CFR 866.3120 — Antiserum, Cf, Psittacosis (Chlamydia Group)
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3120
Identification
Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).
Classification Rationale
Class I (general controls).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GPT | Antiserum, Cf, Psittacosis (Chlamydia Group) | 1 | 1 | 3rd Party |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 1 | 4 | 3rd Party |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 1 | 67 | 3rd Party |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 1 | 35 | 3rd Party |
| LKH | Antisera, Immunoperoxidase, Chlamydia Spp. | 1 | 8 | 3rd Party |
| LKI | Antisera, Fluorescent, Chlamydia Spp. | 1 | 6 | 3rd Party |
| LSK | Dna-Reagents, Chlamydia | 1 | 8 | 3rd Party |
| MGM | C. Trachomatis (Chlamydia Group) | 1 | 0 | 3rd Party |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 1 | 19 | 3rd Party |
