21 CFR 866.3135 — Antigen, Latex Agglutination, Coccidioides Immitis
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3135
Identification
Coccidioides immitis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Coccidioides immitis in serum. The identification aids in the diagnosis of coccidioidomycosis caused by a fungus belonging to the genus Coccidioides and provides epidemiological information on diseases caused by this microorganism. An infection with Coccidioides immitis produces symptoms varying in severity from those accompanying the common cold to those of influenza.
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 |
|---|---|---|---|---|
| GMG | Antigen, Latex Agglutination, Coccidioides Immitis | 2 | 5 | |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 2 | 5 | |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 2 | 11 | |
| MDF | Dna-Probe, Reagents, Coccidioides Immitis | 2 | 1 | |
| MIY | Enzyme Linked Immunosorbent Assay, Coccidioides Immitis | 2 | 1 |
Special Controls
GMG — Antigen, Latex Agglutination, Coccidioides Immitis
*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
GMH — Antiserum, Positive Control, Coccidioides Immitis
*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
GMI — Antigen, Cf And / Or Id, Coccidioides Immitis
*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
MDF — Dna-Probe, Reagents, Coccidioides Immitis
*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
MIY — Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
*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
