GMK · Antiserum, Positive Control, Histoplasma Capsulatum
Microbiology · 21 CFR 866.3320 · Class 2
Overview
| Product Code | GMK |
|---|---|
| Device Name | Antiserum, Positive Control, Histoplasma Capsulatum |
| Regulation | 21 CFR 866.3320 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Histoplasma capsulatum serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Histoplasma capsulatum in serum. Additionally, some of these reagents consist of Histoplasma capsulatum antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Histoplasma capsulatum from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of histoplasmosis caused by this fungus belonging to the genus Histoplasma and provides epidemiological information on the diseases caused by this fungus. Histoplasmosis usually is a mild and often asymptomatic respiratory infection, but in a small number of infected individuals the lesions may spread to practically all tissues and organs.
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.
Special Controls
*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.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K792694 | NEGATIVE CONTROL SERUM | Meridian Diagnostics, Inc. | Jan 24, 1980 | SESE |
| K792692 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | Meridian Diagnostics, Inc. | Jan 24, 1980 | SESE |
| K792718 | HISTOPLASMA CAPSULATUM, ANTISERUM | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K792679 | HISTOPLASMA CAPSULATUM, ANTISERUM | Meridian Diagnostics, Inc. | Jan 17, 1980 | SESE |
| K791395 | ANTI-HISTOPLASMA SERUM #CF10025X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K791392 | ANTI-HISTOPLASMA SERUM #CF10026X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K791390 | ANTI-BLASTOMYCES SERUM #CF10027X | Immuno-Mycologics, Inc. | Aug 16, 1979 | SESE |
| K760832 | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) | I M, Inc. | Nov 1, 1976 | SESE |
| K760831 | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) | I M, Inc. | Nov 1, 1976 | SESE |
Top Applicants
- Meridian Diagnostics, Inc. — 4 clearances
- Immuno-Mycologics, Inc. — 3 clearances
- I M, Inc. — 2 clearances
