Panels › Microbiology › Product code GTQ · Class 1
Antistreptolysin - Titer/Streptolysin O Reagent
Regulation 866.3720
0510(k)s in 12 months (37 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in GTQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Biokit USA, Inc. | 4 | 0 |
| Analytical Products, Inc. | 3 | 0 |
| Beckman Instruments, Inc. | 3 | 0 |
| Behring Diagnostics, Inc. | 3 | 0 |
| Kallestad Diag, A Div. of Erbamont, Inc. | 3 | 0 |
| Texas Immunology, Inc. | 2 | 0 |
| Allied Fisher Scientific | 1 | 0 |
| Ampcor, Inc. | 1 | 0 |
| BD Diagnostic Systems / Lee Laboratories | 0 | 1 |
| Beckman Coulter Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2009 | Remel, Inc Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible fir Terminated |
GTQ | None listed |
| Sep 11, 2008 | BD Diagnostic Systems / Lee Laboratories DIFCO Laboratories, FA Streptococcus Group A, 5mL, Catalog Number: 223181, Lot number: 6122656, Exp: 20090705, in vitro diagnostic. Terminated |
GTQ | None listed |
| Aug 9, 2006 | Roche Diagnostics Corp. Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653 Terminated |
GTQ | None listed |
| Jul 23, 2004 | Beckman Coulter Inc Array Systems Calibrator 5
Part No. 465250 Terminated |
GTQ | K926236 |
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