GTZ · Antisera, All Groups, Streptococcus Spp.
Microbiology · 21 CFR 866.3740 · Class 1
Overview
| Product Code | GTZ |
|---|---|
| Device Name | Antisera, All Groups, Streptococcus Spp. |
| 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 (20 of 105)
Showing 20 most recent of 105 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K012521 | BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST | Binax, Inc. | Nov 30, 2001 | SESE |
| K011709 | UNI-GOLD STREP A TEST KIT | Trinity Biotech, Plc | Nov 8, 2001 | SESE |
| K010523 | MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST | Binax, Inc. | Mar 15, 2001 | SESE |
| K991726 | BINAX NOWR STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST (22 TEST KIT),(12 TEST KIT), BINAX NOWR STREPTOCOCCUS PNEUMONI | Binax, Inc. | Aug 27, 1999 | SESE |
| K971522 | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II | Abbott Laboratories | Mar 3, 1998 | SESE |
| K962060 | STREP A OIA MAX | Biostar, Inc. | Jul 23, 1997 | SESE |
| K962296 | STREPTOLEX-STAT | Unipath , Ltd. | Dec 16, 1996 | SESE |
| K961423 | OSOM STREP A TEST | Wyntek Diagnostics, Inc. | Oct 11, 1996 | SESE |
| K962146 | EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT | Excel Scientific, Inc. | Oct 7, 1996 | SESE |
| K955108 | CARDS Q.S. STREP A | Quidel Corp. | Apr 15, 1996 | SESE |
| K960712 | BINAX STREP A TEST | Binax, Inc. | Mar 22, 1996 | SESE |
| K952819 | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) | Abbott Laboratories | Jan 26, 1996 | SESE |
| K954257 | QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION) | Quidel Corp. | Oct 20, 1995 | SESE |
| K951542 | DIRECTIGEN 1-2-3 GROUP A STREP TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Oct 20, 1995 | SESE |
| K952873 | MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) | Medix Biotech, Inc. | Sep 8, 1995 | SESE |
| K935554 | QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY | Syntron Bioresearch, Inc. | Aug 30, 1995 | SESE |
| K935475 | QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU | Syntron Bioresearch, Inc. | Aug 30, 1995 | SESE |
| K945571 | ABBOTT TEST PACK STREP A TEST | Abbott Laboratories | Aug 14, 1995 | SESE |
| K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) | Pro-Lab, Inc. | Jan 27, 1995 | SESE |
| K942093 | REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST | Medical Diagnostic Technologies, Inc. | Nov 28, 1994 | SESE |
Top Applicants
- Abbott Laboratories — 9 clearances
- Quidel Corp. — 8 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 7 clearances
- Binax, Inc. — 6 clearances
- Diagnostic Products Corp. — 4 clearances
