Product Code: GTQ
FDA class 1
21 CFR 866.3720
Antistreptolysin - Titer/Streptolysin O Reagent
Microbiology
The Antistreptolysin-Titer/Streptolysin O Reagent is a laboratory reagent used to measure antistreptolysin O (ASO) antibody titers in patient serum, serving as an indicator of past or present streptococcal infection and aiding in the diagnosis of conditions such as rheumatic fever and post-streptococcal glomerulonephritis. It is an FDA Class 1 device subject only to general controls, with no premarket clearance required. The product code is GTQ, regulated under 21 CFR 866.3720 in the Microbiology specialty. No special flags apply to this device.
510(k)s
37
FEI Numbers
43
Registration Numbers
43
Unique Applicants
25
Years Active
29
Basic Information
- Product Code
- GTQ
- Device Class
- FDA class 1
- Regulation Number
- 866.3720
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 37 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K052645 | VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; | Dec 14, 2005 | Substantially Equivalent | ORTHO-CLINICAL DIAGNOSTICS |
| K953437 | OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT | Oct 20, 1995 | Substantially Equivalent | OLYMPUS AMERICA, INC. |
| K915742 | TURBIQUANT ASL | Jun 28, 1993 | Substantially Equivalent | BEHRING DIAGNOSTICS, INC. |
| K926236 | BECKMAN ANTI-STREPTOLYSIN O KIT | Jun 15, 1993 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K924247 | ACCUTEX ASO LATEX TEST | Dec 07, 1992 | Substantially Equivalent | J.S. MEDICAL ASSOC. |
| K922723 | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL | Sep 18, 1992 | Substantially Equivalent | SIMPLICITY DIAGNOSTICS, INC. |
| K915053 | BECKMAN ANTISTREPTOLYSIN O, MODIFICATION | Mar 19, 1992 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K912150 | BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT | Jul 17, 1991 | Substantially Equivalent | BECKMAN INSTRUMENTS, INC. |
| K904416 | CROATEST (R) RHEUMATOID DIAGNOSTIC | Jun 24, 1991 | Substantially Equivalent | BIOTRAX, INC. |
| K910887 | QM300 CONTROL G PACK | Jun 17, 1991 | Substantially Equivalent | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
| K910886 | QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK | Jun 17, 1991 | Substantially Equivalent | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
| K910885 | QM300 CALIBRATOR G PACK | Jun 17, 1991 | Substantially Equivalent | KALLESTAD DIAG, A DIV. OF ERBAMONT, INC. |
| K910073 | TARGET ASO TEST | May 21, 1991 | Substantially Equivalent | TEXAS IMMUNOLOGY, INC. |
| K903854 | RAPITEX(R) ASL NEW | Jan 28, 1991 | Substantially Equivalent | BEHRING DIAGNOSTICS, INC. |
| K904311 | RHEUMAGEN ASO T-CONTROL | Jan 25, 1991 | Substantially Equivalent | BIOKIT USA, INC. |
| K901371 | ASO-CUBE(TM) | May 15, 1990 | Substantially Equivalent | DIFCO LABORATORIES, INC. |
| K894486 | QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL) | Oct 24, 1989 | Substantially Equivalent | BIOKIT USA, INC. |
| K894780 | IMMUNO/ASO | Oct 16, 1989 | Substantially Equivalent | IMMUNOSTICS CO., INC. |
| K890025 | QUIK-DOT ANTISTREPTOLYSIN-O | Jan 31, 1989 | Substantially Equivalent | AMPCOR, INC. |
| K881209 | ASO SLIDE TEST | Apr 12, 1988 | Substantially Equivalent | NCS DIAGNOSTICS, INC. |
| K862530 | RAPID AS LATEX | Apr 21, 1987 | Substantially Equivalent | DILAB, INC. |
| K854991 | REUMAGEN ASL | Apr 18, 1986 | Substantially Equivalent | BIOKIT USA, INC. |
| K854039 | LASER ASO KIT | Oct 28, 1985 | Substantially Equivalent | BEHRING DIAGNOSTICS, INC. |
| K853857 | V-TREND ASO PLUS LATEX TEST | Oct 16, 1985 | Substantially Equivalent | TEXAS IMMUNOLOGY, INC. |
| K853276 | ASO SLIDE EIKEN | Aug 20, 1985 | Substantially Equivalent | SYN-KIT, INC. |
| K852701 | FISHER DIAGNOSTIC LATEST ASO TEST KIT | Jul 19, 1985 | Substantially Equivalent | ALLIED FISHER SCIENTIFIC |
| K842839 | SERIMM SURE ASO-CHEK CONTROL SERUM | Aug 23, 1984 | Substantially Equivalent | ANALYTICAL PRODUCTS, INC. |
| K842256 | AS LATEX PLUS | Jun 19, 1984 | Substantially Equivalent | BIOKIT USA, INC. |
| K831464 | ASO-CHECK | Jun 16, 1983 | Substantially Equivalent | DIAGNOSTIC TECHNOLOGY, INC. |
| K831363 | TESTCORP ASO | May 16, 1983 | Substantially Equivalent | CATHETER TECHNOLOGY CORP. |
| K820786 | ASO SURE PLUS | Apr 08, 1982 | Substantially Equivalent | ANALYTICAL PRODUCTS, INC. |
| K820785 | ASO SURE | Apr 08, 1982 | Substantially Equivalent | ANALYTICAL PRODUCTS, INC. |
| K812060 | BI-ASO SLIDE TEST | Aug 13, 1981 | Substantially Equivalent | BIOLOGICS INTL., INC. |
| K801177 | ASO QUANTUM, ANTISTREPTOLYSIN O TEST | Jul 08, 1980 | Substantially Equivalent | SCLAVO, INC. |
| K800642 | RAPI/TEX ASO STANDARD SERUM | Apr 24, 1980 | Substantially Equivalent | CALBIOCHEM-BEHRING CORP. |
| K790831 | ANTISTREPTOLYSIN (ASO) LATEX SLIDE TEST | Jun 15, 1979 | Substantially Equivalent | ICL SCIENTIFIC |
| K760096 | REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O | Aug 03, 1976 | Substantially Equivalent | GAMMA BIOLOGICALS, INC. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.