GTQ · Antistreptolysin - Titer/Streptolysin O Reagent
Microbiology · 21 CFR 866.3720 · Class 1
Overview
| Product Code | GTQ |
|---|---|
| Device Name | Antistreptolysin - Titer/Streptolysin O Reagent |
| 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 (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052645 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; | Ortho-Clinical Diagnostics | Dec 14, 2005 | SESE |
| K953437 | OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | Oct 20, 1995 | SESE |
| K915742 | TURBIQUANT ASL | Behring Diagnostics, Inc. | Jun 28, 1993 | SESE |
| K926236 | BECKMAN ANTI-STREPTOLYSIN O KIT | Beckman Instruments, Inc. | Jun 15, 1993 | SESE |
| K924247 | ACCUTEX ASO LATEX TEST | J.S. Medical Assoc. | Dec 7, 1992 | SESE |
| K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL | Simplicity Diagnostics, Inc. | Sep 18, 1992 | SESE |
| K915053 | BECKMAN ANTISTREPTOLYSIN O, MODIFICATION | Beckman Instruments, Inc. | Mar 19, 1992 | SESE |
| K912150 | BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT | Beckman Instruments, Inc. | Jul 17, 1991 | SESE |
| K904416 | CROATEST (R) RHEUMATOID DIAGNOSTIC | Biotrax, Inc. | Jun 24, 1991 | SESE |
| K910887 | QM300 CONTROL G PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jun 17, 1991 | SESE |
| K910886 | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jun 17, 1991 | SESE |
| K910885 | QM300 CALIBRATOR G PACK | Kallestad Diag, A Div. of Erbamont, Inc. | Jun 17, 1991 | SESE |
| K910073 | TARGET ASO TEST | Texas Immunology, Inc. | May 21, 1991 | SESE |
| K903854 | RAPITEX(R) ASL NEW | Behring Diagnostics, Inc. | Jan 28, 1991 | SESE |
| K904311 | RHEUMAGEN ASO T-CONTROL | Biokit USA, Inc. | Jan 25, 1991 | SESE |
| K901371 | ASO-CUBE(TM) | Difco Laboratories, Inc. | May 15, 1990 | SESE |
| K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) | Biokit USA, Inc. | Oct 24, 1989 | SESE |
| K894780 | IMMUNO/ASO | Immunostics Co., Inc. | Oct 16, 1989 | SESE |
| K890025 | QUIK-DOT ANTISTREPTOLYSIN-O | Ampcor, Inc. | Jan 31, 1989 | SESE |
| K881209 | ASO SLIDE TEST | Ncs Diagnostics, Inc. | Apr 12, 1988 | SESE |
Top Applicants
- Biokit USA, Inc. — 4 clearances
- Analytical Products, Inc. — 3 clearances
- Beckman Instruments, Inc. — 3 clearances
- Behring Diagnostics, Inc. — 3 clearances
- Kallestad Diag, A Div. of Erbamont, Inc. — 3 clearances
