21 CFR 866.3060 — Antigen, Cf, B. Dermatitidis
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3060
Identification
Blastomyces dermatitidis serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Blastomyces determatitidis in serum. The identification aids in the diagnosis of blastomycosis caused by the fungus Blastomyces dermatitidis. Blastomycosis is a chronic granulomatous (tumor-like) disease, which may be limited to the skin or lung or may be widely disseminated in the body resulting in lesions of the bones, liver, spleen, and kidneys.
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 |
|---|---|---|---|---|
| JWW | Antigen, Cf, B. Dermatitidis | 2 | 3 | |
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | 2 | 4 | |
| LSH | Antigen, Blastomyces Dermatitidis, Other | 2 | 0 | |
| LSI | Antiserum, Blastomyces Dermatitidis, Other | 2 | 0 | |
| MDC | Dna-Probe - Blastomyces Dermatitidis | 2 | 1 | |
| MJL | Eia, Blastomyces Dermatitidis | 2 | 2 |
Special Controls
JWW — Antigen, Cf, B. Dermatitidis
*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
KFH — Antiserum, Positive Control, Blastomyces Dermatitidis
*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
LSH — Antigen, Blastomyces Dermatitidis, Other
*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
LSI — Antiserum, Blastomyces Dermatitidis, Other
*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
MDC — Dna-Probe - Blastomyces Dermatitidis
*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
MJL — Eia, Blastomyces Dermatitidis
*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
