LHW · Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Microbiology · 21 CFR 866.3720 · Class 1
Overview
| Product Code | LHW |
|---|---|
| Device Name | Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment |
| Regulation | 21 CFR 866.3720 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Streptococcus spp. exoenzyme reagents are devices used to identify antibodies to Streptococcus spp. exoenzyme in serum. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Streptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K820849 | BLUE RIDGE RABBIT BLOOD | Blue Ridge Media Co. | Apr 16, 1982 | SESE |
| K820848 | BLUE RIDGE SHEEP BLOOD | Blue Ridge Media Co. | Apr 16, 1982 | SESE |
| K813513 | AFRICAN GREEN MONKEY BLOOD IN ALSERVERS | Dutchland Laboratories, Inc. | Dec 31, 1981 | SESE |
| K813512 | RHESUS MONKEY BLOOD IN ALSEVER'S | Dutchland Laboratories, Inc. | Dec 29, 1981 | SESE |
Top Applicants
- Blue Ridge Media Co. — 2 clearances
- Dutchland Laboratories, Inc. — 2 clearances
