Antisera, All Types, Streptococcus Pneumoniae
The Antisera, All Types, Streptococcus Pneumoniae is a collection of type-specific antisera used in laboratory serotyping of Streptococcus pneumoniae isolates, enabling identification of the more than 90 known pneumococcal capsular serotypes for clinical and epidemiological purposes. It is an FDA Class 1 device requiring only general controls, with no premarket clearance needed. Regulated under 21 CFR 866.3740 with product code GWC in the Microbiology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GWC
- Device Class
- FDA class 1
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K884966 | BACTIGEN(R) S. PNEUMONIAE | Feb 07, 1989 | Substantially Equivalent | Armkel, LLC |
| K884965 | BACTIGEN(R) MENINGITIDIS PANEL | Feb 07, 1989 | Substantially Equivalent | Armkel, LLC |
| K870029 | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | Mar 25, 1987 | Substantially Equivalent | American Micro Scan |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Dec 18, 1986 | Substantially Equivalent | Lkb Instruments, Inc. |
| K842239 | VENTRESCREEN STREP A TEST | Jul 02, 1984 | Substantially Equivalent | Ventrex Laboratories, Inc. |
| K841376 | WELLCOGEN S. PNEUMONIAE | May 02, 1984 | Substantially Equivalent | Wellcome Diagnostics |
| K831887 | BACTIGEN S. PNEUMONIAE | Sep 26, 1983 | Substantially Equivalent | Armkel, LLC |
| K821960 | BBL PNEUMOSLIDE TEST | Jul 30, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K802337 | PHADEBACT PNEUMOCOCCUS TEST | Oct 31, 1980 | Substantially Equivalent | Pharmacia, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.