GWC · Antisera, All Types, Streptococcus Pneumoniae
Microbiology · 21 CFR 866.3740 · Class 1
Overview
| Product Code | GWC |
|---|---|
| Device Name | Antisera, All Types, Streptococcus Pneumoniae |
| Regulation | 21 CFR 866.3740 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identify Streptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases 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 § 866.9.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884966 | BACTIGEN(R) S. PNEUMONIAE | Armkel, LLC | Feb 7, 1989 | SESE |
| K884965 | BACTIGEN(R) MENINGITIDIS PANEL | Armkel, LLC | Feb 7, 1989 | SESE |
| K870029 | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | American Micro Scan | Mar 25, 1987 | SESE |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Lkb Instruments, Inc. | Dec 18, 1986 | SESE |
| K842239 | VENTRESCREEN STREP A TEST | Ventrex Laboratories, Inc. | Jul 2, 1984 | SESE |
| K841376 | WELLCOGEN S. PNEUMONIAE | Wellcome Diagnostics | May 2, 1984 | SESE |
| K831887 | BACTIGEN S. PNEUMONIAE | Armkel, LLC | Sep 26, 1983 | SESE |
| K821960 | BBL PNEUMOSLIDE TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 30, 1982 | SESE |
| K802337 | PHADEBACT PNEUMOCOCCUS TEST | Pharmacia, Inc. | Oct 31, 1980 | SESE |
Top Applicants
- Armkel, LLC — 3 clearances
- American Micro Scan — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Lkb Instruments, Inc. — 1 clearance
- Pharmacia, Inc. — 1 clearance
